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 2014-05-30 for URINARY DRAINAGE BAG 24 151 8-CURI manufactured by Unomedical S.r.o..
[4669152]
Details of complaint: "wrong item in the box, 2040 instead of 2048. "
Patient Sequence No: 1, Text Type: D, B5
[11970815]
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. Final quality evaluation was conducted on (b)(4) 2011 based on the information provided by the customer. No sample was available for evaluation; however, our internal investigation shows that on rare occasions different kind of product is packed into the boxes. The mistake was caused by operators inattention, they did not check the item number of packed products. In conclusion, the investigation of this matter has been done previously and the results are available in a documented corrective action preventive action (capa) event. This mdr is being reported as a result of a retrospective review of complaint records conducted by convatec for complaints received from (b)(4) 2011 - september 30, 2013. Reported to the fda on 05/29/2014. Note: the actual date of event is unknown, so the date used was the date convatec became aware. Convatec will continue to track and monitor such complaints according to convatec inc's complaint handling and capa procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005778470-2014-00033 |
| MDR Report Key | 3908224 |
| Report Source | 01,05,06,07,08 |
| Date Received | 2014-05-30 |
| Date of Report | 2011-09-06 |
| Date of Event | 2011-09-06 |
| Date Mfgr Received | 2011-09-06 |
| Date Added to Maude | 2014-07-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, INT. ASS. 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 DRAINAGE BAG |
| Generic Name | KIT, URINARY DRAINAGE COLLECTION |
| Product Code | FCN |
| Date Received | 2014-05-30 |
| Model Number | 24 151 8-CURI |
| Catalog Number | 24 151 8-CURI |
| Lot Number | 396316 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-05-30 |