MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-15 for BARD INFECTION CONTROL URINARY DRAINAGE BAG manufactured by Bard.
[78036449]
Our bard foley bags are leaking where the tube you use to empty them connects to the bag (bad seal). This has probably happened close to 10 times now with different pts. If the urine is leaking then we are unable to correctly measure the urine output, and it is a safety hazard to staff and the pt if the floor is wet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070512 |
| MDR Report Key | 6653103 |
| Date Received | 2017-06-15 |
| Date Added to Maude | 2017-06-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BARD INFECTION CONTROL URINARY DRAINAGE BAG |
| Generic Name | FOLEY BAG |
| Product Code | FAQ |
| Date Received | 2017-06-15 |
| Lot Number | NGAX2094 |
| Device Expiration Date | 2019-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-15 |