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

Model Number 129416M

Device Problems Partial Blockage (1065); Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the reporting nurse placed foley catheter in pre procedure and surgeion verified the placement, no urine returned.But during the procedure surgeon noted the bladder was full.So nurse replaced the foley catheter with new foley and than the bladder was able to drain.

Manufacturer Narrative

The reported event is confirmed, cause unknown.The used three-way eggshell colored latex temperature sensing foley catheter was returned without the original packaging.No visible defects were noted on the catheter.The drainage funnel was connected to the di fountain in an attempt to flush the catheter.Although a specific cause cannot be determined, a potential root cause for this event could be, "biological deposits" or "blocked by clots, etc." no manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use." "routine hygiene (e.G., cleansing of the meatal surface during daily bathing or showering) is appropriate." 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 Description

It was reported that the reporting nurse placed foley catheter in pre procedure and surgeon verified the placement, no urine returned.But during the procedure surgeon noted the bladder was full.So nurse replaced the foley catheter with new foley and than the bladder was able to drain.Per additional information received via mail on 15dec2022, it was reported that the reporting nurse replaced the new foley catheter and the bladder was able to drain.Per additional information received via form with sample returned on 21dec2022, it was reported that the nurse had placed the foley in pre-procedure and surgeon had verified the placement but there was no urine return.During procedure surgeon noted bladder to be full so nurse had placed new foley and than the bladder was able to drain.

• Brand Name: BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: 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: 15916070
• MDR Text Key: 305064253
• Report Number: 1018233-2022-09269
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039775
• UDI-Public: (01)00801741039775
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

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
• Device Operator: Health Professional
• Device Model Number: 129416M
• Device Catalogue Number: 129416M
• Device Lot Number: NGFY0665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 04/04/2023
• Supplement Dates FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female