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

Model Number	119108
Medical Device Problem Codes	Partial Blockage (1065); Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the all-silicone temperature sensing foley catheter was removed and water was injected since there was no urine flow, but the situation did not change.Per additional information received via email from ibc on (b)(6) 2021, it was confirmed that the blockage in the catheter was unknown and there was no urine flow.
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 the all-silicone temperature sensing foley catheter was removed and water was injected since there was no urine flow, but the situation did not change.Per additional information received via email from ibc on 10nov2021, it was confirmed that the blockage in the catheter was unknown and there was no urine flow.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product had caused the reported failure.Visual evaluation of the returned sample 1 used silicone foley.Visual inspection of the sample noted 1 three-way temp sensing catheter the drainage lumen was flushed with 3.5ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water) and the solution did not advance through the funnel observed a blockage on the return sample.This is out of specification per inspection procedure which states, "funnel must not have distortions or bent at shaft connection with the funnel." 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 labelling could not have prevented the reported failure.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.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER
• Common Device Name: TEMPERATURE SENSING 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: 12882664
• Report Number: 1018233-2021-07551
• Device Sequence Number: 12035865
• 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): 05/04/2022

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: 09/11/2025
• Device Model Number: 119108
• Device Catalogue Number: 119108
• Device Lot Number: NGEW0060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• 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