MAUDE Adverse Event Report: UNOMEDICAL S.R.O. URINARY DRAINAGE BAGS; COLLECTOR, URINE, (AND ACCESSORIES)

Model Number 35 030 3 -UMUK

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 05/24/2011

Event Type  malfunction  

Event Description

It was reported that products were rec'd with no labels.

Manufacturer Narrative

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.

• Brand Name: URINARY DRAINAGE BAGS
• Type of Device: COLLECTOR, URINE, (AND ACCESSORIES)
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce 07101 ; LO 07101
• Manufacturer Contact: matthew walenciak, interim associ ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3876086
• MDR Text Key: 4566622
• Report Number: 3005778470-2014-00023
• Device Sequence Number: 1
• Product Code: FCN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/24/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 35 030 3 -UMUK
• Device Catalogue Number: 35 030 3 -UMUK
• Device Lot Number: 403778
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/07/2011
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2011
• 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