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

Model Number	0134L18
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	07/20/2019
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 a water leak was found when the catheter deflated.Per email received from the investigator on (b)(6) 2019, the visual inspection noted the balloon appeared burst.Further inspection noted the balloon to have no missing pieces.
Event or Problem Description
It was reported that a water leak was found when the catheter deflated.
Additional Manufacturer Narrative
The reported event wass confirmed.A lubricath irrigation foley was returned.A clear tube was found in the irrigation funnel and apparent dried residue was on the upper edge of the irrigation funnel.The balloon was found to be burst.A potential root cause could be due to a "high modulus latex".Based on the event the device appeared to be used for treatment.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: ¿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.

• Brand Name: BARDEX®LUBRICATH® FOLEY CATHETER ALCOCK MODEL
• Common Device Name: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8892703
• Report Number: 1018233-2019-04708
• Device Sequence Number: 14135732
• Product Code: KOD
• UDI-Device Identifier: 00801741018756
• UDI-Public: (01)00801741018756
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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 Expiration Date: 05/16/2023
• Device Model Number: 0134L18
• Device Catalogue Number: 0134L18
• Device Lot Number: MCCS3577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1