MAUDE Adverse Event Report: UNOMEDICAL S.R.O. URINARY CATHETER; CONNECTOR, CATHETER

Model Number 02016559

Device Problem Folded (2630)

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

Event Type  malfunction  

Event Description

It was reported that upon receipt, the urinary catheter appeared to have been "folded." during urethra introduction, the urinary catheter, 'folded precisely at the point of initial folding' when being inserted.No pt injuries were reported.

Manufacturer Narrative

Based on the available info, this event is deemed to be a reportable malfunction.There was no reports of the pt being harmed as a result of this malfunction.Add'l pt/event details have been requested.Should add'l info become available, a f/u report will be submitted.

• Brand Name: URINARY CATHETER
• Type of Device: CONNECTOR, CATHETER
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce 0710 1; LO 07101
• Manufacturer Contact: matthew walenciak, assoc. dir. ; 211 american ve; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4641731
• MDR Text Key: 16185693
• Report Number: 3005778470-2015-00003
• Device Sequence Number: 1
• Product Code: GCD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 02016559
• Device Lot Number: 172168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2015
• 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: Initial
• Patient Sequence Number: 1