MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX ALL-SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number 165816

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2022

Event Type  malfunction  

Event Description

During removal of a foley catheter resistance was met.Md at bedside validated and verified that the balloon was deflated, and he slowly began to withdraw catheter.There was minimal blood noted at the tip of the patient's penis upon removal and the catheter was inspected and it was noted that one of the ribbed rings from the tip of the catheter had folded onto itself which could have been the cause of the resistance upon removal.No injury or harm to the patient.

• Brand Name: BARDEX ALL-SILICONE FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 13860121
• MDR Text Key: 287673016
• Report Number: 13860121
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Device Lot Number: NGFU5124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17885 DA
• Patient Sex: Male
• Patient Weight: 35 KG
• Patient Ethnicity: Hispanic