MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® LUBRICATH® FOLEY CATHETER; FOLEY CATHETERS

Model Number	365724
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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 24 inch long foley catheter was filled with 8cc of water, and the balloon burst inside the patients bladder during usage.
Additional Manufacturer Narrative
The reported issue was confirmed.The device was returned for evaluation.Visual inspection observed a sac burst opposite the lumen.There was no missing pieces observed.Introduced water into the inflation lumen and did not experience any obstructions to impede flow.Microscopic examination found no conditions that could be associated with the reported event.However the exact cause of how and when the problem occurred could not be determined.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿for urological use only warning: on catheter, do not use ointments or lubricants having a petroleum base.They will damage latex and may cause balloon to burst" h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the 24 inch long foley catheter was filled with 8cc of water, and the balloon burst inside the patients bladder during usage.

• Brand Name: BARD® LUBRICATH® FOLEY CATHETER
• Common Device Name: FOLEY CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9558383
• Report Number: 1018233-2020-00157
• Device Sequence Number: 14168274
• Product Code: EZC
• UDI-Device Identifier: 00801741077784
• UDI-Public: (01)00801741077784
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/28/2023
• Device Model Number: 365724
• Device Catalogue Number: 365724
• Device Lot Number: 9BS143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1