Device product
BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
Z-1317-2015
Product summary
- Event
- Event 70593
- Status
- Terminated
- Classification
- Class II
- Quantity
- 315,800 units
- Official record key
device-enforcement:Z-1317-2015
Official wording
Reason: Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
Code information: Lot #'s 4128925 and 4128926
Distribution pattern: Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA.
Derived failure modes
-
Unknown
Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.