Device product
1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1809600, UDI: (01)00801741027130 ; 2. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Without Suture Plugs, REF: 1809601, UDI: (01)00801741027147; 3. PowerPort M.R.I. Implantable Port With Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1859600, UDI: (01)00801741027208 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Z-1571-2020
Product summary
- Event
- Event 84914
- Status
- Terminated
- Classification
- Class II
- Quantity
- 878 Catheters
- Official record key
device-enforcement:Z-1571-2020
Official wording
Reason: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Code information: 1. Lot #s 1809600- RECR1434, RECT0091 2. Lot #s 1809601- RECT0189, 3. Lot #s 1859600- RECR2072, RECS1118
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,VA, VT, WA, WI, WV, WY and countries of Brazil, Canada, EMEA, Korea, Mexico, New Zealand.
Derived failure modes
-
Unknown
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.