MAUDE Adverse Event Report: UNOMEDICAL S.R.O. URINARY DRAINAGE BAG; KIT, URINARY DRAINAGE COLLECTION

Model Number 24 151 8-CURI

Device Problems Misassembled (1398); Incomplete or Missing Packaging (2312); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2011

Event Type  malfunction  

Event Description

Details of complaint: "wrong item in the box, 2040 instead of 2048.".

Manufacturer Narrative

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.

• Brand Name: URINARY DRAINAGE BAG
• Type of Device: KIT, URINARY DRAINAGE COLLECTION
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce 07101 ; LO 07101
• Manufacturer Contact: matthew walenciak, int. ass. dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3908224
• MDR Text Key: 4669152
• Report Number: 3005778470-2014-00033
• Device Sequence Number: 1
• Product Code: FCN
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24 151 8-CURI
• Device Catalogue Number: 24 151 8-CURI
• Device Lot Number: 396316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1