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

Model Number	165810
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
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 the balloon had a protruding ridge around the tip of the catheter after the balloon was deflated during a pretest, prior to insertion.Further inspection noted that the package identifies the balloon as being 3cc yet the product itself is listed as a 5ml balloon.The patient was being prepped for surgery when this incident occurred.Per follow up response received via mail 17 dec 2020, the user had reported another occurrence of a pediatric catheter balloon after deflation with a noticeable ridge present.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.One sample was confirmed to exhibit the reported failure.Visual evaluation of the returned sample noted one opened (without original package) unused silicone foley was received.Visual inspection of the sample noted that the catheter balloon had ridges on opposite sides of the balloon extending down its length.A potential root cause for this failure mode could be due to the balloon material did not shrink quickly enough.The device did not meet the specifications and was influenced by the reported failure.The product was not used for the treatment.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, reseat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol." correction: e 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 the balloon had a protruding ridge around the tip of the catheter after the balloon was deflated during the pretest prior to insertion.Further inspection noted that the package identifies the balloon was being 3cc yet the product itself was listed as a 5ml balloon.The patient was being prepped for surgery when the incident was occurred.Per a follow up response received via email on (b)(6) 2020 it was stated that the user reported another occurrence of a pediatric catheter balloon after deflation with a noticeable ridge was present.

• Brand Name: BARDEX PEDIATRIC ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11089986
• Report Number: 1018233-2020-22118
• Device Sequence Number: 3922633
• Product Code: KOD
• UDI-Device Identifier: 00801741029721
• UDI-Public: (01)00801741029721
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 01/15/2025
• Device Model Number: 165810
• Device Catalogue Number: 165810
• Device Lot Number: NGEQ0959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 9 YR
• Patient Weight: 79