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

Device Problems Material Invagination (1336); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2019

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 catheter's balloon had rolled in on itself creating a donut around the tip upon inspection.The catheter had been removed by force.It was unknown if this was by the patient or medical professional.The catheter had been in use for 5 hours.No medical intervention was reported.

Event Description

It was reported that the catheter's balloon had rolled in on itself creating a donut around the tip upon inspection.The catheter had been removed by force.It was unknown if this was by the patient or medical professional.The catheter had been in use for 5 hours.No medical intervention was reported.

Manufacturer Narrative

This report is being submitted past the regulatory timeframe.Please see attached letter for additional information.The device was not returned for evaluation.A potential failure mode could be ¿cuffing¿ with a potential root cause of ¿balloon material does not shrink quickly enough¿.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the all silicone catheter product labeling are found to be adequate based on past reviews.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8494957
• MDR Text Key: 141570022
• Report Number: 1018233-2019-01774
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1