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

Model Number 806316

Device Problems Material Invagination (1336); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

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 balloon of the silicone foley catheter mushroomed during use making it difficult to remove.Patient was taken to the emergency room where a urologist was brought in to remove the catheter.The method of catheter removal is unknown.The complainant is unable or unwilling to provide any additional information regarding the event.

Manufacturer Narrative

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.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.".

Event Description

It was reported that the balloon of the silicone foley catheter mushroomed during use making it difficult to remove.Patient was taken to the emergency room where a urologist was brought in to remove the catheter.The method of catheter removal is unknown.The complainant is unable or unwilling to provide any additional information regarding the event.

• Brand Name: BARDIA® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8611681
• MDR Text Key: 145103326
• Report Number: 1018233-2019-02561
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741039119
• UDI-Public: (01)00801741039119
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 806316
• Device Catalogue Number: 806316
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 05/30/2019
• Supplement Dates FDA Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other