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

Model Number	0196L18
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the customer had 2 foley catheters where the balloon developed a crack.They replaced catheter with a second one and it did the same thing.There was no exposure to the patient or to the health care worker and no harm to the patient.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.A red 2 way foley catheter was returned opened without original packaging.It was noted the catheter balloon had a tear.Using a luer lock syringe the catheter was attempted to be inflated with 10 ccs of di water.The di water began to spray from the tear of the catheter balloon.Sample does not meet specification, as it would not pass functional - leak testing.As it is unknown what caused the balloon tear the event will be confirmed cause unknown.The product was used for treatment purposes.A potential root cause for this failure could be "over inflation during use" or "exposure to petrolatum based lubricant or other degrading materials".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: "warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst." "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." 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 the customer had 2 foley catheters where the balloon developed a crack.They replaced catheter with a second one and it did the same thing.There was no exposure to the patient or to the health care worker and no harm to the patient.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUNCILL MODEL
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12787620
• Report Number: 1018233-2021-07175
• Device Sequence Number: 17350646
• Product Code: EZC
• UDI-Device Identifier: 00801741017933
• UDI-Public: (01)00801741017933
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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: 08/31/2023
• Device Model Number: 0196L18
• Device Catalogue Number: 0196L18
• Device Lot Number: NGDS4292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2019
• 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