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

Model Number	0134L22
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2020
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.
Event or Problem Description
It was reported that water leaked soon after the placement.
Additional Manufacturer Narrative
The reported event is confirmed as manufacturing-related.An amber lubricath foley was returned without its original packaging.A 10cc leur lock syringe was used to infuse water in the balloon.Water was found to be coming out of the device's lower drainage eye indicative of a lumen-to-lumen leak.The possible root causes could be due to "mechanical failure, incorrect recipe, program error, machine fault, over filling of dip tank, or level sensor failure".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: ¿recommended inflation capacities 3cc balloon: use 5ml sterile water; 5cc balloon: use 10ml sterile water; 15cc balloon: use 20ml sterile water; 20cc balloon: use 25ml sterile water; 30cc balloon: use 35ml sterile water; 40cc balloon: use 45ml sterile water; 75cc balloon: use 80ml sterile water.Do not exceed recommended capacities.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations." 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 water leaked soon after the placement.

• Brand Name: BARDEX®LUBRICATH® FOLEY CATHETER ALCOCK MODEL
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9853185
• Report Number: 1018233-2020-01913
• Device Sequence Number: 2415741
• Product Code: KOD
• UDI-Device Identifier: 00801741018770
• UDI-Public: (01)00801741018770
• 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): 05/15/2020

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 Expiration Date: 09/26/2022
• Device Model Number: 0134L22
• Device Catalogue Number: 0134L22
• Device Lot Number: MCBW4884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1