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 - INTRA ABDOMINAL PRESSURE MONITOR DEVICE ABV301 manufactured by Convatec, Inc..
[39311261]
Exp date 05/2017. Based on the available information, this event is deemed to be a reportable malfunction. 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
[39311262]
It was reported that the auto-valve in the abviser intra-abdominal pressure monitor would not deflate after 60 hours of use. The device was removed and replaced, no patient harm resulted due to the reported complaint.
Patient Sequence No: 1, Text Type: D, B5
[42186399]
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. Mfg date: device manufacture date corrected. The following codes were reported in error on the initial mfr#: 1049092-2016-00071 , reported to the fda on february 29, 2016: results code, conclusion code. The following codes were omitted from the initial mfr#: 1049092-2016-00071, reported to the fda on february 29, 2016 and are being corrected on this report: method code, conclusion code. 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
[46268764]
A used autovalve product sample was returned for physical analysis to determine the potential root cause. The unit was opened, and proper assembly and components were verified. The filter was cleaned and a particle was found lodged in the 0. 0015" diameter laser drilled timing hole, which had prevented it from draining. Product monitoring reviews will continue to monitor for product trends if this issue were to reoccur. No further actions are required, and the complaint will be closed. 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 | 1049092-2016-00071 |
| MDR Report Key | 5468245 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-02-29 |
| Date of Report | 2016-02-04 |
| Date of Event | 2016-02-02 |
| Date Mfgr Received | 2016-05-09 |
| 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 - INTRA ABDOMINAL PRESSURE MONITOR 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, SUITE 400 GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-29 |