MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06,foreign,other,user f report with the FDA on 2015-06-22 for ABVISER AUTOVALVE IAP MONITORING DEVICE ABV301 manufactured by Convatec, Inc.
[22252354]
It was reported the auto valve was not fully inflating/closing. The device was replaced with a new device.
Patient Sequence No: 1, Text Type: D, B5
[22313321]
Based on the available info, this event is deemed to be a reportable malfunction. There wer no reports of the pt being harmed as a result. Should additional info become available a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[59237569]
Add'l information was received on july 01, 2015 confirming a return product was received. The device was decontaminated using 10% bleach solution. Product was released to supplier quality. 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
[59238019]
Additional information was received on (b)(6) 2015. Third party manufacturer reviewed the historical work order for lot# 140600 which revealed that all testing met specifications. The returned unit was evaluated and did not function properly. The unit was examined under a microscope and showed that the valve assembly was correctly assembled but there was a rupture of the green silicone diaphragm. This caused the autovalve to not inflate properly. Third party manufacturer indicated that the green diaphragm rupture is usually caused by inconsistent pressure force performed while infusing fluid into the bladder. They were able to replicate the issue. No previous investigations are available. After a thorough review of the returned product and batch review no discrepancies or non-conformances were discovered. There is not enough information to conclude the product did not meet specification and perform as intended. Product monitoring reviews will monitor for product trends if this issue were to reoccur. No further actions are required and the complaint will be closed. Sections have been updated to reflect the correct information. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. Reported to the fda on september 11, 2015. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2015-00360 |
| MDR Report Key | 4861607 |
| Report Source | 00,01,06,FOREIGN,OTHER,USER F |
| Date Received | 2015-06-22 |
| Date of Report | 2015-06-10 |
| Date of Event | 2015-06-09 |
| Date Mfgr Received | 2015-08-14 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2015-06-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MATTHEW WALENCIAK |
| Manufacturer Street | 211 AMERICAN AVENUE |
| 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 AUTOVALVE IAP MONITORING DEVICE |
| Product Code | FEN |
| Date Received | 2015-06-22 |
| Returned To Mfg | 2015-06-16 |
| Model Number | ABV301 |
| Lot Number | 140600 |
| Device Expiration Date | 2019-05-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-06-22 |