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

Catalog Number	165810
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, urine did not flow from the foley catheter.The drainage lumen may be blocked.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.No actions can be taken at this time since a root cause was not identified.Visual: received 1 silicone foley catheter.Drained water through drainage funnel and no water drained out of drainage eyes therefore funnel appears to be blocked.Dissected balloon and inserted 0.040 pin gauge into drainage funnel to see drainage funnel pathway.However, pin gauge does not go through drainage funnel all the way indicating the drainage funnel was not extruded throughout the catheter.Dhr review did not show any problems or conditions that would have contributed to the reported event.Labelling review is not required as labelling would not have prevented the reported event.Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that during the surgery, urine did not flow from the foley catheter.The drainage lumen may be blocked.

• 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 GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20396831
• Report Number: 1018233-2024-06308
• Device Sequence Number: 15018113
• Product Code: KOD
• UDI-Device Identifier: 00801741029721
• UDI-Public: (01)00801741029721(11)230719(17)280430(10)NGHS3190
• 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): 01/21/2025

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 Catalogue Number: 165810
• Device Lot Number: NGHS3190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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