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

Model Number	0167V24S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2020
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.The device was not returned.
Event or Problem Description
It was reported when attempting to deflate a foley catheter balloon.No fluid was present in the balloon.The balloon was pulled and the catheter was found to have a ruptured balloon.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to a "high modulus latex".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the 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 when attempting to deflate a foley catheter balloon.No fluid was present in the balloon.The balloon was pulled and the catheter was found to have a ruptured balloon.

• Brand Name: BARDEX FOLEY CATHETER SILICONE COATED
• Common Device Name: FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10082648
• Report Number: 1018233-2020-03321
• Device Sequence Number: 2916243
• Product Code: KOD
• UDI-Device Identifier: 00801741019241
• UDI-Public: (01)00801741019241
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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: Health Professional
• Device Model Number: 0167V24S
• Device Catalogue Number: 0167V24S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 06/28/2020
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1