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

Model Number	119108
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
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.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 when the catheter was tested prior to insertion, there was no balloon deflation, but during the procedure, the catheter fell out and when checked, there was a hole.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.Visual evaluation noted received 2 three-way catheters.Attempted to inflate first catheter balloon with 3.5 ml of solution and it immediately leaked out of a 0.011" pinhole found on the balloon.Attempted to inflate second catheter balloon with 3.5 ml of solution and the solution immediately went into the drainage lumen from the balloon.Dissected balloon and found that the notch was double perforated.Therefore, product does not meet specifications which states "verify that the eye punches are complete and notch according to the applicable drawing." although an exact root cause could not be determined a potential root cause could be: notch design (id undersized); notch placement (nicks drainage lumen); no notch.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labelling review is not required as labelling would not have prevented the reported event.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 when the catheter was tested prior to insertion, there was no balloon deflation, but during the procedure, the catheter fell out and when checked, there was a hole.As per the investigator notification received on 06jun2023, there was double perforation of the notch.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16911727
• Report Number: 1018233-2023-03334
• Device Sequence Number: 15343999
• Product Code: EZL
• UDI-Device Identifier: 00801741045998
• UDI-Public: (01)00801741045998
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070582
• 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): 08/03/2023

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: 06/18/2026
• Device Model Number: 119108
• Device Catalogue Number: 119108
• Device Lot Number: NGFT1007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• 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