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

Model Number	0168L12
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
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 foley catheter was difficult to deflate on the next day of the placement.The patient was sent to another hospital for successful removal.Per follow up via ibc on (b)(6) 2022, the method used to remove the catheter was probably cut and removed.
Additional Manufacturer Narrative
The reported event was inconclusive due to a poor sample.An amber 2 way foley catheter was returned opened without original packaging.Photo samples were also returned.In both the photo and physical samples the catheter was noted to be cut into 4 pieces.The inflation cap was cut off in 2 separate sections, and the catheter shaft was cut in 2.Unable to test for deflation issues with the sample returned.The catheter balloon was noted to be burst.As this was not reported and it is unknown if it was caused by an attempt to deflate the balloon, an additional complaint will not be opened.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be, "operator error".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 action is required at this time.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: "to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol." the actual/suspected device was inspected.
Event or Problem Description
It was reported that the foley catheter was difficult to deflate on the next day of the placement.The patient was sent to another hospital for successful removal.Per follow up via ibc on 26jan2022, the method used to remove the catheter was probably cut and removed.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP
• Common Device Name: FOLEY CATHETER COUDE TIP
• 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: 13467684
• Report Number: 1018233-2022-00434
• Device Sequence Number: 4779757
• 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): 07/06/2022

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: 0168L12
• Device Catalogue Number: 0168L12
• Device Lot Number: NGEU1897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 02/06/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2020
• 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