Device product
BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
Z-0125-2021
Product summary
- Event
- Event 86434
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,020 units
- Official record key
device-enforcement:Z-0125-2021
Official wording
Reason: Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted
Code information: Lot Number: 9325212 UDI: 30382903835387
Distribution pattern: US: Nationwide Distribution: AK, AR, AZ, CA, IL, KS, MO, NY, OH, UT, VA; and International to: Canada and Mexico.
Derived failure modes
-
Unknown
Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted