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

Model Number	01237524
Medical Device Problem Codes	Burst Container or Vessel (1074); Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
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 the customer had two issues this week with defective foley catheters.The first one had a small leak.The second one had a balloon that broke.Per follow up made on (b)(6) 2021, initially it was reported that the balloon burst on the second patient but instead when tested and noted, the balloon was intact and the leak was inside the balloon and no pieces were missing.The second one was inflated with 80ml of saline water.Per additional information via email on (b)(6) 2021, customer mentioned that they had one more balloon burst.Per additional follow up information received on 20mar2021, there was no missing pieces from this balloon and 80cc fluid was inflated with saline.No medical intervention was reported other than patient inconvenience.
Event or Problem Description
It was reported that the customer had two issues this week with defective foley catheters.The first one had a small leak.The second one had a balloon that broke.Per follow up made on 12mar2021, initially it was reported that the balloon burst on the second patient but instead when tested and noted, the balloon was intact and the leak was inside the balloon and no pieces were missing.The second one was inflated with 80ml of saline water.Per additional information via email on 17mar2021, customer mentioned that they had one more balloon burst.Per additional follow up information received on 20mar2021, there was no missing pieces from this balloon and 80cc fluid was inflated with saline.No medical intervention was reported other than patient inconvenience.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.One sample was confirmed to exhibit the reported failure.An amber 2-way foley catheter was returned opened without original packaging.The catheter balloon was attempted to be inflated with 80 ccs of di water using a luer lock syringe.Water began to spray from the drainage eye during inflation.Lumen to lumen leakage is the cause of the reported event.The product does not meet specification, as it would fail functional leak testing.A potential root cause for this failure could be "operator error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not required as the reported event is confirmed manufacturing related.The actual/suspected device was inspected.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: LUBRICATH 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: 11627579
• Report Number: 1018233-2021-01934
• Device Sequence Number: 3898992
• Product Code: EZC
• UDI-Device Identifier: 00801741017742
• UDI-Public: (01)00801741017742
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K910195
• 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): 12/09/2021

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: 08/31/2024
• Device Model Number: 01237524
• Device Catalogue Number: 01237524
• Device Lot Number: NGET1985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2020
• 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