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

Model Number	143112
Medical Device Problem Codes	Component Missing (2306); Component Misassembled (4004)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2021
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 that the suprapubic catheter kit that had the luer-lock hub for filling the balloon was missing in the kit.Follow up via phone on 06nov2020, the device was not used on a patient.
Event or Problem Description
It was reported that the suprapubic catheter kit had the luer-lock hub for filling the balloon was missing in the kit.Per follow-up via phone on 06nov2020, the device was not used on a patient.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.One sample was confirmed to exhibit the reported failure.An amber two way foley catheter was returned without its original packaging.The inflation valve of the catheter was found to be missing.Product does not meet specification which states "each catheter will have the valve and cap checked for proper valve and cap placement, print presence, and any valve or cap defect such as cracked valves, cracked caps, short valve/cap assemblies etc." a potential root cause for this failure could be "machine malfunction".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed as the reported event was confirmed as manufacturing related.Correction: h.H11: section a through f - the information provided by bard 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 bard.The actual/suspected device was inspected.
Event or Problem Description
It was reported that the suprapubic catheter kit had the luer-lock hub for filling the balloon was missing in the kit.Per follow-up via phone on (b)(6) 2020, the device was not used on a patient.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10932199
• Report Number: 1018233-2020-21237
• Device Sequence Number: 14343404
• Product Code: EZC
• UDI-Device Identifier: 00801741040542
• UDI-Public: (01)00801741040542
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2021

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: 12/31/2023
• Device Model Number: 143112
• Device Catalogue Number: 0165L12
• Device Lot Number: NGDW1872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 01/09/2021; 08/03/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 01/28/2021; 08/27/2021
• 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