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

Model Number	0168L12
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foley catheter came off about 10 minutes after inserting into the patient.After the catheter removal, the user put water again into the balloon and it deflated when the water was left for about 5 to 10 minutes.There was no balloon rupture or tear and the patient did not have any urine stone.It was stated that hand glove would have possibly contacted to the balloon.As per the additional information via email from ibc on 18may2022, no visible damage was observed to the returned sample.
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 foley catheter came off about 10 minutes after inserting into the patient.After the catheter removal, the user put water again into the balloon and it deflated when the water was left for about 5 to 10 minutes.There was no balloon rupture or tear and the patient did not have any urine stone.It was stated that hand glove would have possibly contacted to the balloon.As per the additional information via email from ibc on 18may2022, no visible damage was observed to the returned sample.
Additional Manufacturer Narrative
The reported event is confirmed, manufacturing related.Photo samples were submitted, however, no defects were noted based on the photos.The lubricath coude foley catheter was returned without the original packaging.No visible defects were noted on the catheter.The coude tip aligned with the coude indicator.An attempt was made to inflate the catheter balloon with 10cc di water using a luer lock syringe, however, as the balloon was being inflated the water leaked from the drainage eye preventing proper inflation.All 10cc water leaked from the drainage eye and the balloon completely deflated on it's own; lumen to lumen leak was determined to be the cause of the deflation issues.The catheter does not meet specifications as it would not pass functional leak.A potential root cause for this event could be, "operator error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A label/pack review is not required as a review of the label could not have prevented the reported event.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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14564962
• Report Number: 1018233-2022-04259
• Device Sequence Number: 20069614
• 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): 09/27/2022

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: 08/31/2024
• Device Model Number: 0168L12
• Device Catalogue Number: 0168L12
• Device Lot Number: NGEN0766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2020
• 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