MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE FOLEY CATHETER

Model Number 165816

Device Problem Nonstandard Device (1420)

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

Event Date 05/26/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient on bedrest post heart catheter and foley inserted due to retention upon discontinuation of foley after bedrest being up, resistance was met attempting to discontinue device.The representative called for assistance, and they lubricated the foley and reinserted the foley after verifying the balloon was deflated and irrigation the foley with saline in attempt to break up any clots after visualizing bloody urine in the tubing and reattempted to pull out the foley with no success.They were able to pull foley to the tip of the penis, but no further without meeting resistance.At this point, they relubricated the catheter and continued to irrigate until the catheter eventually came out.Upon inspection of the catheter tip, the area of the balloon appeared to be default and ridged, and the catheter was sticking out all around and not smooth.The nurse was notified, and the tip was cut and left for their inspection.An additional kit was opened, and the balloon was noted to had ridges, not smooth and the balloon on that kit was inflated and deflated and fold in material was noted upon deflation.No medical intervention was reported.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.The device was not returned.

Event Description

It was reported that the patient on bedrest post heart catheter and foley inserted due to retention upon discontinuation of foley after bedrest being up, resistance was met attempting to discontinue device.The representative called for assistance, and they lubricated the foley and reinserted the foley after verifying the balloon was deflated and irrigation the foley with saline in attempt to break up any clots after visualizing bloody urine in the tubing and reattempted to pull out the foley with no success.They were able to pull foley to the tip of the penis, but no further without meeting resistance.At this point, they relubricated the catheter and continued to irrigate until the catheter eventually came out.Upon inspection of the catheter tip, the area of the balloon appeared to be default and ridged, and the catheter was sticking out all around and not smooth.The nurse was notified, and the tip was cut and left for their inspection.An additional kit was opened, and the balloon was noted to had ridges, not smooth and the balloon on that kit was inflated and deflated and fold in material was noted upon deflation.No medical intervention was reported.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14713689
• MDR Text Key: 301903468
• Report Number: 1018233-2022-04688
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• 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 Outcome(s): Other