Device product
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Z-0025-2024
Product summary
- Event
- Event 92970
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 98,000 units
- Official record key
device-enforcement:Z-0025-2024
Official wording
Reason: There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed.
Code information: Lot # 2238464/ UDI-DI: (01)00382903868629
Distribution pattern: US Nationwide distribution in the states of CA, FL, GA, MA, MN, MO, MS, NJ, OH, TX.
Derived failure modes
-
Unknown
There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed.