MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® PEDIATRIC ALL-SILICONE FOLEY CATHETER

Model Number	165810
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
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 it was difficult to deflate the foley catheter during pretest.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.1 sample were confirmed to exhibit the reported failure.The reported failure is considered out of specification as the reported failure was reproduced.The product was not used for patient treatment.The product caused the reported failure.A potential root cause for this failure mode could be ¿foreign matter during processes (flap or flash during punching)".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The investigation is concluded, and no additional action is required at this time.The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.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.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 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 inspected.
Event or Problem Description
It was reported that it was difficult to deflate the foley catheter during pretest.

• Brand Name: BARDEX® PEDIATRIC ALL-SILICONE FOLEY CATHETER
• 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: 14886247
• Report Number: 1018233-2022-05064
• Device Sequence Number: 6307191
• Product Code: KOD
• UDI-Device Identifier: 00801741029721
• UDI-Public: (01)00801741029721
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K821745
• 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): 12/12/2022

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: 06/17/2026
• Device Model Number: 165810
• Device Catalogue Number: 165810
• Device Lot Number: NGFT0814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• 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