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

Catalog Number 165816

Device Problem Mushroomed (2987)

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

Event Type  malfunction  

Event Description

It was reported that the balloon mushroomed.

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,
• Type of Device: EZL
• 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: 4355935
• MDR Text Key: 5178695
• Report Number: 1018233-2014-00351
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 165816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/17/2014
• 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