MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-06-16 for ABVISER AV IAP DEVICE, POLE MOUNT (1X10) ABV301 manufactured by Convatec, Inc..
[47594784]
Based on the available information, this event is deemed to be a malfunction. The instructions for use say to ensure the urinary catheter to valve connection is dry and then wrap a strip of tape (included in the package) around the end of the catheter to keep it snugly attached to the abviser autovalve valve. 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
[47594805]
Information reported by a distributor indicated that the auto valve of the abviser disconnected from the foley catheter while injecting normal saline. The device had been in use for forty hours. The indication for use of the device was intestinal swelling which needed regular intra-abdominal pressure (iap) monitoring. The patient was in the supine position with the head of the bed flat when the measurement was taken,there was no resistance felt at the time of the event. It is unclear if the blue tape was provided with the kit or was applied to the connection between the auto-valve and the catheter, as this information was unavailable. The abviser was replaced with a new one; no harm was reported to the patient as a result of the disconnection. The patient's current status is being kept in surgical intensive care unit under observation.
Patient Sequence No: 1, Text Type: D, B5
[48981880]
Received (1) one used abviser for evaluation. The returned product sample has been forwarded to the original equipment manufacturer for further investigation. 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
[51493665]
A batch record review for lot# 140600 was performed by the original equipment manufacturer (oem) and showed that all functional testing met the specification. There were two sub-assembly lot#s; 140428 and 140444 used to manufacture lot# 140600. Review of lot# 140428 shows that all functional testing met specification. However, lot# 140444 did have a non-conformance related to the qa in-process flow test process. The non-conformance does not affect the overall intact of the valve (i. E. ,the non-conformance is not related o the complaint issue. ) a physical sample was received for this complaint, and evaluated. The used (decontaminated) product sample was returned to the oem where it was examined under a microscope. The product sample showed major cracks all around the valve cap and valve body area, which could cause the valve to detach during usage. 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 | 1049092-2016-00282 |
| MDR Report Key | 5730246 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-06-16 |
| Date of Report | 2016-05-30 |
| Date of Event | 2016-05-28 |
| Date Mfgr Received | 2016-07-27 |
| Date Added to Maude | 2016-06-16 |
| 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 AV IAP DEVICE, POLE MOUNT (1X10) |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2016-06-16 |
| Returned To Mfg | 2016-06-17 |
| Model Number | ABV301 |
| Lot Number | 140600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-06-16 |