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

Model Number	0168L12
Medical Device Problem Codes	Failure to Infuse (2340); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
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.
Event or Problem Description
It was reported that when the syringe was connected to the inflation funnel and the syringe was pushed, the foley catheter balloon did not inflate due to water leakage.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.One sample exhibited the reported failure.The device had not met specifications.The reported failure is considered out of specification as the reported failure was reproduced.The product was not used for patient treatment or diagnosis.The product caused the reported failure.A potential root cause for this failure could be machine malfunction.Visual evaluation of the returned 2-way foley catheter.Inflation cap noted to not be seated correctly on the catheter.Attempted to inflate catheter with 10 ml methylene blue solution and solution leaked from underneath the inflation cap.This is out of specification per inspection procedure , which states, the cap must be present, the height and position must be correct.Inclined cap not allowed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.Correction: d,f,h h11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that when the syringe was connected to the inflation funnel and the syringe was pushed, the foley catheter balloon did not inflate due to water leakage.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP
• Common Device Name: FOLEY CATHETER COUDE TIP
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13252560
• Report Number: 1018233-2021-08798
• Device Sequence Number: 11908494
• Product Code: EZC
• UDI-Device Identifier: 00801741017803
• UDI-Public: (01)00801741017803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: 01/31/2025
• Device Model Number: 0168L12
• Device Catalogue Number: 0168L12
• Device Lot Number: NGEU0411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown