MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2014-05-15 for URINARY DRAINAGE BAGS 35 030 3 -UMUK manufactured by Unomedical S.r.o..
[4566622]
It was reported that products were rec'd with no labels.
Patient Sequence No: 1, Text Type: D, B5
[12088597]
Based on the available info, this event is deemed a reportable malfunction. A final quality investigation was performed on (b)(4) 2011. The investigation results stated the following, rec'd one box with 25 bags packed into polybags. The labels which should be placed in the middle of the polybags are missing on each of them. History records have been checked and no deviation was observed during the mfg process. No other complaints of this nature have been rec'd on the same batch and also on the same reference code. The defect occurred due to operator mistake who forgot to put the labels on the polybags during the packing process. All relevant operators will be retrained. Corrective action has been implemented. Effectiveness of action was verified by inspection after training. Corrective action was effective. No add'l pt/event details have been provided to date. Should add'l info become available, a f/u report will be submitted. This mdr is being reported as a result of a retrospective review of complaint records conducted by (b)(4) for complaints rec'd from (b)(4) 2011 - (b)(4) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005778470-2014-00023 |
| MDR Report Key | 3876086 |
| Report Source | 01,07,08 |
| Date Received | 2014-05-15 |
| Date of Report | 2011-05-24 |
| Date of Event | 2011-05-24 |
| Date Mfgr Received | 2011-05-24 |
| Date Added to Maude | 2014-06-30 |
| 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, INTERIM ASSOCI |
| 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 DRAINAGE BAGS |
| Generic Name | COLLECTOR, URINE, (AND ACCESSORIES) |
| Product Code | FCN |
| Date Received | 2014-05-15 |
| Returned To Mfg | 2011-06-07 |
| Model Number | 35 030 3 -UMUK |
| Catalog Number | 35 030 3 -UMUK |
| Lot Number | 403778 |
| 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 | 2014-05-15 |