MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 2014-08-01 for URINARY CATHETERS 90 820 1S-10 manufactured by Unomedical S.r.o..
[15908421]
A leak was reported.
Patient Sequence No: 1, Text Type: D, B5
[15955846]
Based on the available information, this event is deemed a reportable malfunction. Additional information received on may 30, 2014 informing the leak of the catheter valve required replacement with a new catheter. A quality evaluation was performed on (b)(4) 2014. The sample in closed peel pack has been received and tested: the valve was connected to the tube and filled up with colored water and hung up for 24 hours to monitor the valve tightness. The valves was opened and closed several times. Sample met the tests requirements. History files of the batch manufacturing process have been checked. No nonconformity has been registered during the manufacturing process. No earlier complaint has been received on the batch in question. Based on the investigation findings and information received it has not been possible to determine the root cause of the failure in question. There is no indication of an adverse trend of complaints over the past twelve months for this issue/product. The failure was included in relevant risk management file and associated hazard was evaluated there. Based on investigation results no further action is required. 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 | 3005778470-2014-00053 |
| MDR Report Key | 4088340 |
| Report Source | 01,05,06,07,08 |
| Date Received | 2014-08-01 |
| Date of Report | 2014-05-28 |
| Date of Event | 2014-05-28 |
| Date Mfgr Received | 2014-05-28 |
| Date Added to Maude | 2014-09-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, INT. ASSOC DIR |
| Manufacturer Street | 211 AMERICAN AVE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URINARY CATHETERS |
| Generic Name | CLAMP, CANNULA |
| Product Code | FKC |
| Date Received | 2014-08-01 |
| Returned To Mfg | 2014-06-05 |
| Model Number | 90 820 1S-10 |
| Catalog Number | 90 820 1S-10 |
| Lot Number | 492977 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL S.R.O. |
| Manufacturer Address | PRIEMYSELNY PARK 3 MICHALOVCE 07101 LO 07101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-01 |