MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD BARDEX 2 WAY SILICONE FOLEY CATHETER

Catalog Number 165812

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2013

Event Type  malfunction  

Event Description

It was reported that a cuff roll was noted on the balloon upon catheter removal.Resistance was noted upon removal.The catheter tip was noted intact and there was no injury to the pt.

Manufacturer Narrative

Investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

• Brand Name: BARDEX 2 WAY SILICONE FOLEY CATHETER
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD; km, 7 carretera internacional; nogales, sonora 8562 1; MX 85621
• Manufacturer Contact: kim shirah ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 3736436
• MDR Text Key: 4223685
• Report Number: 1018233-2014-00024
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 165812
• Device Lot Number: NGXF0633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 10 YR