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

Model Number	806316
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that the balloon of the silicone foley catheter mushroomed during use making it difficult to remove.The patient was taken to the emergency room where a urologist was brought in to remove the catheter.The method of the catheter removal is unknown.The complainant is unable or unwilling to provide any additional information regarding the event.
Event or Problem Description
It was reported that the balloon of the silicone foley catheter mushroomed during use making it difficult to remove.The patient was taken to the emergency room where a urologist was brought in to remove the catheter.The method of the catheter removal is unknown.The complainant is unable or unwilling to provide any additional information regarding the event.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be " balloon cuffing".A potential root cause for this failure could be "incorrect balloon position length due to the balloon was not stretched after balloon position." 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.".

• Brand Name: BARDIA® ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8611677
• Report Number: 1018233-2019-02557
• Device Sequence Number: 11317875
• Product Code: EZL
• UDI-Device Identifier: 00801741039119
• UDI-Public: (01)00801741039119
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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
• Operator of Device: Health Professional
• Device Model Number: 806316
• Device Catalogue Number: 806316
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other