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

Model Number	0168L18
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer had the same issue with the foley catheter twice now.It was stated that the first time was in april, the customer felt liquid on leg one night and found water draining out of attachment for balloon.The catheter collapsed and slid out.And the second time was two weeks ago on july 28th at the doctor's office.Nurse replaced with new catheter and then it started draining again while they were still in the doctor's office.
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 the same issue with the foley catheter twice now.It was stated that the first time was in april, the customer felt liquid on leg one night and found water draining out of attachment for balloon.The catheter collapsed and slid out.And the second time was two weeks ago on july 28th at the doctor's office.Nurse replaced with new catheter and then it started draining again while they were still in the doctor's office.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "imperfection in balloon due to process".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions are needed.The device was not returned for evaluation.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: "storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use." 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.

• 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: 15249659
• Report Number: 1018233-2022-06530
• Device Sequence Number: 17754225
• Product Code: EZC
• UDI-Device Identifier: 00801741017834
• UDI-Public: (01)00801741017834
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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 Model Number: 0168L18
• Device Catalogue Number: 0168L18
• Device Lot Number: NGGS0740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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