BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LATEX FOLEY CATHETER

    MDR report key: 14273658 · Received May 4, 2022

    Report

    Report Number
    1018233-2022-03209
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    April 6, 2022
    Report Date
    May 9, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE DUE TO THIN SAC COULD CAUSE POOR SHAPE/ BAGGY SAC & NON- CONCENTRIC BALLOON. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE PRODUCT CATALOG NUMBER FOR THIS DEVICE WAS UNKNOWN. THEREFORE, BD WAS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER INQUIRED FOR A WRITTEN PDF MATERIAL ON THE CORRECT WAY OF REMOVING A BARD FOLEY CATHETER. IT WAS ALSO REPORTED THAT THE CUSTOMER HAD AN ISSUE THE PREVIOUS DAY WHERE A FOLEY CATHETER WAS PLACED IN ALLEGHENY GENERAL HOSPITAL AND THE PATIENT WAS SENT TO GOOD SAMARITAN REGIONAL MEDICAL CENTRE ICU. STATED THAT UPON DEFLATING THE BALLOON, IT FOLDED AND CREATED AN O-RING INSTEAD OF LYING FLAT. CUSTOMER WAS UNSURE IF THE CATHETER USED WAS A BARD CATHETER OR NOT. IT WAS ALSO REPORTED THAT THE SAME ISSUE HAD OCCURRED WITH A BARD CATHETER ON (B)(6) 2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER INQUIRED FOR A WRITTEN PDF MATERIAL ON THE CORRECT WAY OF REMOVING A BARD FOLEY CATHETER. IT WAS ALSO REPORTED THAT THE CUSTOMER HAD AN ISSUE THE PREVIOUS DAY WHERE A FOLEY CATHETER WAS PLACED IN ALLEGHENY GENERAL HOSPITAL AND THE PATIENT WAS SENT TO GOOD SAMARITAN REGIONAL MEDICAL CENTRE ICU. STATED THAT UPON DEFLATING THE BALLOON, IT FOLDED AND CREATED AN O-RING INSTEAD OF LYING FLAT. CUSTOMER WAS UNSURE IF THE CATHETER USED WAS A BARD CATHETER OR NOT. IT WAS ALSO REPORTED THAT THE SAME ISSUE HAD OCCURRED WITH A BARD CATHETER ON 06APR22.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501046 LATEX FOLEY CATHETER UNKNOWN FOLEY CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other