Device product
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180
Z-0800-2024
Product summary
- Firm
- C.R. Bard Inc
- Event
- Event 93679
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 57159 units
- Official record key
device-enforcement:Z-0800-2024
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 00801741113260, Lot/Serial Numbers: NGDT2000, NGDX0518, NGEW1822, NGEW3855, NGEX0043, NGEX1998, NGEZ2693, NGFP0406, NGFP3519, NGFR0244, NGFT0418, NGFT3481, NGFU3821, NGFV0785, NGFV1654, NGFV3445, NGFW1906, NGFX0169, NGFX2674, NGFX5527, NGGP3171
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.