MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2016-08-04 for ABVISER?AUTOVALVE IAP MONITORING DEVICE, POLE ABV301 manufactured by Convatec Inc..
[51188793]
Based on the available information, this event is deemed to be a reportable malfunction. No patient harm was reported. One abviser was received attached to a saline bag for evaluation. The saline bag was discarded. The device was decontaminated with 10% bleach water and thoroughly dried. The device was forwarded to the third party supplier for evaluation. Additional details have been requested but not provided to date. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[51188794]
Complaint received from a dealer reporting that an auto-valve malfunction had occurred with the device. Reporter stated "on third day of usage, the auto-valve did not open. It resulted in the urine and saline could not be drained. " reporter stated that the device was replaced. No patient information was provided.
Patient Sequence No: 1, Text Type: D, B5
[55801913]
The batch record for abv301, lot# 141133 was reviewed by the manufacturer and showed that all functional testing met the specification and indicates no discrepancies related to the complaint issue. There was a deviation issued to the batch record, due to the replacing of saline with distilled water during post sterile functional testing. The deviation has no effect on the product complaint. The sub-assembly batch records used for building abv301 were reviewed by the manufacturer and no issue were found. A photograph and physical sample have been received for evaluation. The valve was opened and evaluated under the microscope and exhibited that the valve assembly had a missing micro filter component. The micro filter main purpose is to prevent any particulates from occluding the 0. 0015" diameter laser drilled timing hole. The laser drilled timing hole was found occluded with foreign particulate inside. 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. Reported to the fda on september 28, 2016. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2016-00361 |
| MDR Report Key | 5847805 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2016-08-04 |
| Date of Report | 2016-07-21 |
| Date of Event | 2016-07-20 |
| Date Mfgr Received | 2016-09-15 |
| Device Manufacturer Date | 2014-11-13 |
| Date Added to Maude | 2016-08-04 |
| 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, POLE |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2016-08-04 |
| Model Number | ABV301 |
| Lot Number | 141133 |
| 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 AVENUE GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-04 |