Device product
Bard¿ Lopez Valve¿ with ENFit, REF EN0056000
Z-0801-2024
Product summary
- Firm
- C.R. Bard Inc
- Event
- Event 93679
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 187550 units
- Official record key
device-enforcement:Z-0801-2024
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 00801741113901, Lot/Serial Numbers: NGFU2486, NGFU3807, NGFW1859, NGFX0062, NGFX5625, NGFY0610, NGFZ1664, NGGR0346, NGGR2172, NGGS0703, NGGS2557, NGGS3418, NGGYY001, NGHN0893, NGHQ3357, NGHQ3358, NGHQ3359, NGHQ3383, NGHQ3384, NGHR0028, NGHR0029, NGHR0030, NGHR0031, NGHR0032, NGHR0072, NGHR0073, NGHR0074, NGHR0075, NGHR0159, NGHV0889, NGHV2621, NGHV2722, NGHV3877, NGHW0569, NGHW1488, NGHW3036, NGHW4578, NGHX0643, NGHX0869
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.