MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2014-10-14 for ABVISER-INTRA ABDOMINAL PRESSURE MONITOR ABV321 manufactured by Convatec, Inc..
[5022644]
It is reported that after nine (9) days of placement of the device on a pt from the icu, insufflation with 20cc of saline solution was performed. Although the measure of the intra-abdominal pressure was taken correctly, the automatic valve did not collapse.
Patient Sequence No: 1, Text Type: D, B5
[12255584]
Based on the available info, this event is deemed a reportable malfunction. There were no reports of the pt being harmed as a result of this malfunction. The physician waited for some minutes and decided to remove the device since the pt was not in a critical state. The device was discarded and upon revision the day after, the valve was still distended. An investigation was performed by the third party manufacturing site that included a historical review of the batch records for the past six months to date of manufacture of the complaint lot. All the testings met specification and performance requirements. No root cause was determined since the device had been discarded. No add'l pt/event details have been provided to date. A return sample for eval is not expected. Should add'l info become available, a f/u report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2014-00517 |
| MDR Report Key | 4181171 |
| Report Source | 01,07,08 |
| Date Received | 2014-10-14 |
| Date of Report | 2014-09-18 |
| Date of Event | 2014-09-17 |
| Date Mfgr Received | 2014-09-18 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2014-10-21 |
| 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, 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 | ABVISER-INTRA ABDOMINAL PRESSURE MONITOR |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2014-10-14 |
| Model Number | ABV321 |
| Catalog Number | ABV321 |
| Lot Number | 130217 |
| Device Expiration Date | 2016-02-11 |
| 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 | 2014-10-14 |