MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER

Catalog Number 165816

Device Problems Difficult to Remove (1528); Sticking (1597); Cut In Material (2454); Material Protrusion/Extrusion (2979)

Patient Problem Swelling (2091)

Event Type  malfunction  

Event Description

It was reported that while removing the catheter from the urethra the catheter became stuck.When the nurse was called to the room she also tried to remove the foley, but it would not move.The inflation valve was cut, no fluid would drain.The patient was palpated and a hard nodule was felt approximately 1 inch into the urethra.Urology was called to remove the catheter.Upon removal a raise ridge was discovered at the tip of the catheter.

Manufacturer Narrative

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

• Brand Name: BARDEX 2-WAY 5CC ALL-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: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 3982913
• MDR Text Key: 4633664
• Report Number: 1018233-2014-00164
• 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: Other
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 165816
• Device Lot Number: NGXL1169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: No
• 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