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

Catalog Number	0167L20
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
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.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.
Event or Problem Description
It was reported that during surgery the surgeon was doing a cystolitholapaxy procedure when placing the lubricath, 3-way, specialty, latex, medium round tip, two staggered drainage eyes around the bladder as they went to inflate the balloon it would not inflate and they noticed a hole in it.They had the actual devise and could send it in for investigation.There was no patient harm.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (with original labeling), used foley catheter.Visual inspection of the sample noted inflated the catheter balloon with 30 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and no leaks were observed.With the syringe attached the balloon deflated passively with no issues.No root cause could be found because the reported event was unconfirmed.The dhr review is not required as the s the reported event is unconfirmed.As the reported event is unconfirmed a labeling review is not required.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 during surgery the surgeon was doing a cystolitholapaxy procedure when placing the lubricath, 3-way, specialty, latex, medium round tip, two staggered drainage eyes around the bladder as they went to inflate the balloon it would not inflate and they noticed a hole in it.They had the actual devise and could send it in for investigation.There was no patient harm.

• 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
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17754614
• Report Number: 1018233-2023-06803
• Device Sequence Number: 6768307
• Product Code: KOD
• UDI-Device Identifier: 00801741018961
• UDI-Public: (01)00801741018961
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

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 Catalogue Number: 0167L20
• Device Lot Number: NGHS1475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 01/06/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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