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

Model Number	0134L22
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
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 catheter fell out after the surgery due to water leakage.Catheter was inserted again, but it fell out.Probably, the water leaked from the lumen to the lumen.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.One sample was confirmed to exhibit the reported failure.The device had not met specifications.The product had caused the reported failure.A potential root cause for this failure could be "operator error".An amber 3 way foley catheter was returned.The catheter was attempted to be inflated with 30 ccs of di water using a luer lock syringe.Water began to spray from the irrigation eye.Lumen to lumen leakage is the cause of the deflation issue.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required as the reported event is confirmed manufacturing related.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.H3 other text : the actual/suspected device was evaluated.
Event or Problem Description
It was reported that the catheter fell out after the surgery due to water leakage.Catheter was inserted again, but it fell out.Probably, the water leaked from the lumen to the lumen.

• Brand Name: BARDEX®LUBRICATH® FOLEY CATHETER ALCOCK 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: 12075852
• Report Number: 1018233-2021-03835
• Device Sequence Number: 11731882
• Product Code: KOD
• UDI-Device Identifier: 00801741018770
• UDI-Public: (01)00801741018770
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/06/2022

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: 0134L22
• Device Catalogue Number: 0134L22
• Device Lot Number: NGES2162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2020
• 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