MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-18 for HOLLISTER VENTED URINARY LEG BAG COMBINATION PACK * 9655 manufactured by Hollister Incorporated.
[4553213]
The patient was discharged home following a procedure with a foley catheter attached to the hollister leg bag. The patient's mother called the hospital later to report that the bag was connected to the catheter upside-down. Reviewing the connection procedure with other nurses, it appeared that all of them would have connected the bag upside-down and the way the bag should be attached was counter-intuitive, leading to possible future errors in attaching the bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3763204 |
| MDR Report Key | 3763204 |
| Date Received | 2014-04-18 |
| Date of Report | 2014-02-12 |
| Date of Event | 2013-12-26 |
| Report Date | 2014-02-12 |
| Date Reported to FDA | 2014-04-18 |
| Date Reported to Mfgr | 2014-04-22 |
| Date Added to Maude | 2014-04-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOLLISTER VENTED URINARY LEG BAG COMBINATION PACK |
| Generic Name | BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE |
| Product Code | NNW |
| Date Received | 2014-04-18 |
| Model Number | * |
| Catalog Number | 9655 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLLISTER INCORPORATED |
| Manufacturer Address | 2000 HOLLISTER DRIVE LIBERTYVILLE IL 60048 US 60048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-18 |