MAUDE Adverse Event Report: UNOMEDICAL SDN BHD SILICONIZED 2-WAY, HARD VALVE, CH08; CATHETER, RETENTION TYPE, BALLOON

Model Number MM53120805

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 04/02/2012

Event Type  malfunction  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21 cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

It was reported that the catheter shafts appear snaky.

• Brand Name: SILICONIZED 2-WAY, HARD VALVE, CH08
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): UNOMEDICAL SDN BHD; bakar arang ind estate; sungai petani; kedah, 08000 ; MY 08000
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5188639
• MDR Text Key: 29866728
• Report Number: 9611710-2015-31102
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K770256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/01/2017
• Device Model Number: MM53120805
• Device Lot Number: 405255R001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• 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