BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATLOCK IV ULTRA PED CATH RETAINER, ULTRA PED PADS 50 BOX

    MDR report key: 11826713 · Received May 14, 2021

    Report

    Report Number
    3006260740-2021-01874
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 6, 2021
    Report Date
    June 16, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE ANALYSIS, APPLICABLE FMEA DOCUMENTS, APPLICABLE MANUFACTURING RECORDS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A BROKEN STATLOCK WAS CONFIRMED, BUT THE EXACT CAUSE COULD NOT BE DETERMINED. ONE STATLOCK IV STABILIZATION DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE EXHIBITED EVIDENCE OF USE. THE BLUE RETAINER WAS BROKEN, WHICH ALLOWED ONE HALF OF THE SUBSTRATE TO SEPARATE FROM THE OTHER HALF. THE FRACTURE SURFACES OF THE RETAINER EXHIBITED AN UNEVEN AND JAGGED SURFACE, WHICH IS CONSISTENT WITH A BREAK DUE TO BENDING. SINCE THE FRACTURE WAS OBSERVED ON THE RETURNED SAMPLE, THE COMPLAINT WAS CONFIRMED; HOWEVER, THERE WERE NO DISTINGUISHING FEATURES WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC MECHANISM OF DAMAGE. BENDING STRESSES AND/OR CHEMICAL DEGRADATION MAY HAVE BEEN POTENTIAL CONTRIBUTING FACTORS OF THE OBSERVED DAMAGE. IT WAS REPORTED THAT THE IV WAS USED FOR 5 DAYS, WHICH INDICATES THAT THE STATLOCK WAS NOT BROKEN AT THE TIME OF PLACEMENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO REJECTS, CHANGES TO THE MANUFACTURING PROCESS, OR ANYTHING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED CATHETER WAS PLACED WITH UNSECURED STAT LOCK. PATIENT WAS BLEEDING AND UPON FURTHER INSPECTION WHEN DRESSING WAS REMOVED, IT WAS NOTED THE IV CATHETER WAS COMPLETELY OUT AND STAT LOCK WAS BROKEN.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUEZ1785 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED CATHETER WAS PLACED WITH UNSECURED STAT LOCK. PATIENT WAS BLEEDING AND UPON FURTHER INSPECTION WHEN DRESSING WAS REMOVED, IT WAS NOTED THE IV CATHETER WAS COMPLETELY OUT AND STAT LOCK WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722929 STATLOCK IV ULTRA PED CATH RETAINER, ULTRA PED PADS 50 BOX STAND, INFUSION KMK C.R. BARD, INC. (BASD) -3006260740 N/A JUEZ1785

    Patients

    Seq Age Sex Outcome Treatment
    1 Other