MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-02-29 for ABVISER AUTOVALVE IAP MONITORING DEVICE ABV301 manufactured by Convatec Inc..
[39308991]
On (b)(6) 2017. (b)(6). On (b)(6) 2014. Based on the available information, this event is deemed to be a reportable malfunction. No further information was provided. No patient information was provided. No additional details have been provided to date. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[39308993]
It was reported that after six (6) hours of usage, the auto-valve was detached when injecting normal saline. A picture was also received depicting the reported complaint issue.
Patient Sequence No: 1, Text Type: D, B5
[42188002]
No previous investigations are available. A detailed, six (6) month batch record review for the associated lot was conducted and revealed that all samples subjected to the operational timing test met specifications. However, a root cause could not be determined because the auto-valve in question was not available for physical analysis. No discrepancies (including non-conformances/deviations) were found and 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. A product sample was received however, only the diaphragm transducer section of the abviser was included. The return sample has been forwarded to the appropriate party for evaluation. (b)(4). No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[47643637]
A batch record review indicated a discrepancy in one of the subassembly lots (# 140444) for a high flow in the qa in-process flow test which was not related to this complaint failure. Sub-lot # 140444 was subjected to 100% testing prior to release. No additional investigation is needed. This issue will be monitored through the post market product monitoring review process. No additional patient/ event details have been provided to date. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2016-00070 |
| MDR Report Key | 5468465 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-02-29 |
| Date of Report | 2016-02-04 |
| Date of Event | 2016-02-02 |
| Date Mfgr Received | 2016-05-25 |
| Device Manufacturer Date | 2014-05-28 |
| Date Added to Maude | 2016-02-29 |
| 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 | MRS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABVISER AUTOVALVE IAP MONITORING DEVICE |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2016-02-29 |
| Returned To Mfg | 2016-03-28 |
| Model Number | ABV301 |
| Lot Number | 140600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC INC. |
| Manufacturer Address | 211 AMERICAN AVENUE GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-29 |