MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-09-10 for ABVISER AUTOVALVE VALVE IAP MONITORING DEVICE WITH ICU MEDICAL TRANSPAC TRANSDUC ABV331 manufactured by Convatec, Inc..
[25503989]
Based on the available information, this event is deemed a reportable malfunction. There were no reports of the patient being harmed as a result of this malfunction. Additional patient/event details have been requested. However, no additional information was available at the time of the report. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[25503990]
It was reported that after one day in use, the rn noted that urine was not flowing in the device. The device was removed and it was discovered that the green occlusion device remained inflated. There was no issue with urethral catheter. The rn further reported that the patient had 800 milliliters of urine output after removal of the device. A new device was placed and there were no further issues reported. The patient was sedated and ventilated and did not exhibit any complaints.
Patient Sequence No: 1, Text Type: D, B5
[30472528]
Additional information was received on (b)(6) , 2015. Third party manufacturer confirmed no lot number was available for the returned unit for traceability. Therefore a six month historical batch record review was performed for lot# abv331 from (b)(6) 2015. All samples post sterilization were subjected to the air test for the auto valve function which met the specification for operational timing. The abvisor requires a 100% air test during the manufacturing process to ensure the auto valve functions properly. The sample was visually examined under the microscope and the it was discovered that the timing hole was clogged with a soft material particle, yellow and brown in color. It was too small to determine the exact source. After thoroughly investigating the particle it could be grease or oil that accumulated over time during the patients use and led to the clog in the timing hole. No previous investigations are available. After a review of the returned product and a thorough batch review no discrepancies, non-conformances or deviations were found. 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. 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
| Report Number | 1049092-2015-00531 |
| MDR Report Key | 5069602 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-09-10 |
| Date of Report | 2015-08-13 |
| Date of Event | 2015-08-13 |
| Date Mfgr Received | 2015-10-21 |
| Date Added to Maude | 2015-09-10 |
| 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 |
| Manufacturer G1 | CONVATEC, INC. |
| Manufacturer Street | 211 AMERICAN AVENUE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABVISER AUTOVALVE VALVE IAP MONITORING DEVICE WITH ICU MEDICAL TRANSPAC TRANSDUC |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2015-09-10 |
| Returned To Mfg | 2015-08-25 |
| Model Number | ABV331 |
| Operator | NURSE |
| 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 GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-10 |