MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-10 for ADVISER AUTOVALVE IAP MONITORING DEVICE WITH E ABV321 manufactured by Convatec, Inc..
[21847062]
The critical care educator colleen ryan, registered nurse reports that the green valve in the autovalve did not deflate with one unit out of a case of 10. The registered nurse caring for the patient states that the patient was voiding around the foley catheter rather than through the catheter. The registered nurse attempted to irrigate the foley catheter and then changed the foley catheter, but the urine continued to drain around the catheter rather than through the catheter. The registered nurse removed the abviser and the urine then started to drain.
Patient Sequence No: 1, Text Type: D, B5
[22023352]
Based on the available information, this event is deemed a serious injury. No additional patient/event details have been provided to date. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2014-00613 |
| MDR Report Key | 4338159 |
| Report Source | 05,06 |
| Date Received | 2014-12-10 |
| Date of Report | 2014-11-13 |
| Date of Event | 2014-11-11 |
| Date Mfgr Received | 2014-11-13 |
| Date Added to Maude | 2014-12-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, DIR. INTERIM A |
| Manufacturer Street | 211 AMERICAN AVE. |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVISER AUTOVALVE IAP MONITORING DEVICE WITH E |
| Product Code | FEN |
| Date Received | 2014-12-10 |
| Model Number | ABV321 |
| Lot Number | 140437 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC, INC. |
| Manufacturer Address | 211 AMERICAN AVE. GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-12-10 |