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

Model Number	01267522
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
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 inflation valve was broken.When attempting to use the catheter in the operating room, the syringe did not fit properly into the valve portion.Upon checking, the inflation valve had been broken.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.A reported event is confirmed.The three-way latex foley catheter was returned.An exact root cause could not be determined a potential root cause could be operator error.Gross visual evaluation: the inflation cap appeared to be melted with a piece of the blue sleeve stuck to the cap, no additional defects were noted on the catheter.The device was not returned for evaluation.Microscopic visual observation: the cap was viewed under the microscope at 5x and 6x magnification; confirming the blue sleeve melted onto the cap; this is out of specifications."operator should be alert to obvious defective catheters and / or caps." although an exact root cause could not be determined a potential root cause could be operator error.The device history record was reviewed and found a possible manufacturing issue(s) 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.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." 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.
Event or Problem Description
It was reported that the inflation valve was broken.When attempting to use the catheter in the operating room, the syringe did not fit properly into the valve portion.Upon checking, the inflation valve had been broken.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER CREEVY 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16371222
• Report Number: 1018233-2023-00863
• Device Sequence Number: 6814261
• Product Code: EZC
• UDI-Device Identifier: 00801741018817
• UDI-Public: (01)00801741018817
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910195
• 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): 04/06/2023

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: 01267522
• Device Catalogue Number: 01267522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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