Device product
Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
Z-0795-2024
Product summary
- Firm
- C.R. Bard Inc
- Event
- Event 93679
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 39430 units
- Official record key
device-enforcement:Z-0795-2024
Official wording
Reason: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Code information: UDI/DI 00801741113765, Lot/Serial Numbers: NGEV2409, NGEY1492, NGEY2717, NGEZ0908, NGEZ1657, NGEZ2692, NGFQ4105, NGFR1077, NGFR2312, NGFR3259, NGFS1627, NGFS4431, NGFT5468, NGFU1877, NGFU3837, NGFV1652, NGFV3513, NGFW1856, NGFX0167, NGFX2672, NGFX5611, NGGP3169, NGGT3611
Distribution pattern: US
Derived failure modes
-
Unknown
BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.