MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,08 report with the FDA on 2014-05-08 for URINARY DRAINAGE BAGS 15 958 8-CURI manufactured by Unomedical S.r.o..
[4396767]
Info ref. On the complaint report is stated as follows: "the wrong bags in the cartons, item 8027 should be included only 8019-370858-curi is packed in this box. (wrong product in box)".
Patient Sequence No: 1, Text Type: D, B5
[11744953]
Based on the available info, this event is deemed a reportable malfunction. There were no reports of the pt being harmed as a result of this malfunction. Final quality eval was conducted on (b)(4) 2011 based on the info provided by the customer and sample received which was one box with 25 pcs of bags. The box is marked with label (15 958 8-curi), inside the box there are bags of item (37 085 8-curi). Results are as follows: the sample was tested and did not perform to our requirements. An analysis to determine the potential root causes indicates that the mistake occurred during the packing process due to operator mistake, who most likely packed different type of bags into the inner boxes. The procedure for start-up and completion of the order "line clearance" concerning packaging and labeling was not followed. The results will be used to implement appropriate actions to prevent this issue from recurring. All relevant personnel who were packing the production order in question will be re-trained on line clearance procedure. Additionally, we have implemented strict rules for completing the order quantity of products in batch (e. G. Missing quantity due to increased waste). In conclusion, the appropriate personnel will be contacted to verify that products used for batch completion are in accordance with the specification and drawing. Note: this mdr is being reported as a result of a retrospective review of complaint records conducted by (b)(4) for complaints received from (b)(4) 2011 - (b)(4) 2013. Convatec will continue to track and monitor such complaints according to (b)(4) complaint handling and capa procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005778470-2014-00020 |
| MDR Report Key | 3830007 |
| Report Source | 01,06,07,08 |
| Date Received | 2014-05-08 |
| Date of Report | 2011-06-21 |
| Date of Event | 2011-06-21 |
| Date Mfgr Received | 2011-06-21 |
| Date Added to Maude | 2014-05-27 |
| 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, DIRECTOR |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URINARY DRAINAGE BAGS |
| Generic Name | KIT, URINARY DRAINAGE COLLECTION |
| Product Code | FCN |
| Date Received | 2014-05-08 |
| Returned To Mfg | 2011-07-21 |
| Model Number | 15 958 8-CURI |
| Catalog Number | 15 958 8-CURI |
| Lot Number | 311041 |
| 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 | 2014-05-08 |