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

Catalog Number	119314M
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley catheter did not deflate when it was checked before insertion by a labor and delivery nurse.Device was saved.
Additional Manufacturer Narrative
The reported event is unconfirmed.Visual evaluation noted received 1 silicone foley catheter with syringe.Using returned syringe catheter was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).Inflated with no difficulties and deflated passively under one minute.Using in house lock leur syringe catheter was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).Inflated with no difficulties and deflated passively under one minute.Dissected balloon indicated inflation notch was as intended.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The reported event is unconfirmed a labeling review is not required.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.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19546971
• Report Number: 1018233-2024-03504
• Device Sequence Number: 4734985
• Product Code: MJC
• UDI-Device Identifier: 00801741039904
• UDI-Public: (01)00801741039904
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2024

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: 119314M
• Device Lot Number: NGHS2842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2023
• 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