MAUDE Adverse Event Report: UNOMEDICAL S.R.O. URINARY DRAINAGE BAGS; KIT, URINARY DRAINAGE COLLECTIONS

Model Number 24 111 8-10

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

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

Event Date 08/31/2011

Event Type  malfunction  

Event Description

Details of complaint: "customer ordered (b)(6), received a box marked with (b)(6) but packed with another product.".

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.An investigation was conducted on (b)(4) 2011 based on the information provided by the customer and sample(s) received.The sample provided was tested and did not perform to our requirements.An analysis to determine the potential root cause indicates that the mistake was caused by operator inattention.It is concluded that the operators did not check the item number of packed products.Note: this mdr is being reported as a result of a retrospective review of complaint records conducted by convatec for complaints received from may 01, 2011 - september 30, 2013.Reported to the fda on (b)(4) 2014.Note: the actual date of event (b3) 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 BAGS
• Type of Device: KIT, URINARY DRAINAGE COLLECTIONS
• 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: 3908210
• MDR Text Key: 4668577
• Report Number: 3005778470-2014-00032
• Device Sequence Number: 1
• Product Code: FCN
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/31/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24 111 8-10
• Device Catalogue Number: 24 111 8-10
• Device Lot Number: 364888
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/06/2011
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2011
• Was Device Evaluated by Manufacturer?: Yes
• 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