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

Model Number	119108
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
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 no urine flowed after the placement and the temperature sensing catheter was changed.Water was tried to inject from the main lumen, but it was unable to do.Since the catheter was replaced during the operation some operations were hindered.Per follow up information received on 10nov2021, customer would like to confirm the drainage lumen obstruction and tried to inject from drainage lumen, but they could not.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.The device has not met specifications.The product was used for treatment.The product had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used temperature sensing silicone foley catheter.A potential root cause for this failure could be incorrect setup.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.Corrections: d,f,h.H11: section a through f - the information provided by bard 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 bard.
Event or Problem Description
It was reported that no urine flowed after the placement and the temperature sensing catheter was changed.Water was tried to inject from the main lumen, but it was unable to do.Since the catheter was replaced during the operation some operations were hindered.Per follow up information received on 10nov2021, customer would like to confirm the drainage lumen obstruction and tried to inject from drainage lumen, but they could not.Per sample evaluation from the investigator via email on 27apr2022, the temperature sensing wire was noted to be tangled.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER
• Common Device Name: TEMPERATURE-SENSING PEDIATRIC 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12859864
• Report Number: 1018233-2021-07469
• Device Sequence Number: 19906599
• 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): 05/12/2022

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: 05/06/2025
• Device Model Number: 119108
• Device Catalogue Number: 119108
• Device Lot Number: NGEP0705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2020
• 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