MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-09 for THE ABVISER AUTOVALVE IAP MONITORING DEVICE ABV331 manufactured by Convatec, Inc..
[6832032]
The complainant reports the abviser autovalve iap monitoring device was placed for an obstruction in a pediatric patient. When the nurse attempted to infuse saline into the double check valve began to leak. The abviser was replaced. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[13973090]
Based on the available information, this event is deemed a reportable malfunction. The initial reporter was unable to determine the lot number of the affected product. Additional patient/event details have been requested. There were no reports of the patient being harmed as a result of this malfunction. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2015-00387 |
| MDR Report Key | 4908340 |
| Report Source | 06 |
| Date Received | 2015-07-09 |
| Date of Report | 2015-06-19 |
| Date Mfgr Received | 2015-06-19 |
| Date Added to Maude | 2015-07-17 |
| 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, INT ASSOC DIR |
| 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 | THE ABVISER AUTOVALVE IAP MONITORING DEVICE |
| Product Code | FEN |
| Date Received | 2015-07-09 |
| Model Number | ABV331 |
| 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 | 2015-07-09 |