BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT PLASTIC CANNULA

    MDR report key: 13983999 · Received April 1, 2022

    Report

    Report Number
    1911916-2022-00180
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 9, 2022
    Report Date
    March 23, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903033454
    PMA / PMN Number
    K974363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. INVESTIGATION SUMMARY : EXEC SUMMARY - NO PHYSICAL DEVICE SAMPLES WERE RETURNED. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AND THE ROOT CAUSE IS UNDETERMINED. HOWEVER FOR A RUBBER CORE BEING PUSHED THROUGH FROM THE VILE DEFECT OCCURS BECAUSE THE CUSTOMER IS NOT USING THE PRODUCT AS INTENDED. A REVIEW OF THE COMPLAINT LOT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR (RUBBER CORE PUSHED THROUGH ON VILE OF PROPOFOL) ON THIS LOT # 1260085. NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. CAPA/SA - BASED ON THE ABOVE NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE OR PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME. DHR REVIEW - A LOT HISTORY REVIEW FOR BATCH 1260085 WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD BLUNT PLASTIC CANNULA HAD CORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE DISTRIBUTOR REPORTED THAT A RUBBER CORE PUSHED THROUGH THE NEEDLE ON A VILE OF PROPOFOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869657 BD BLUNT PLASTIC CANNULA HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 1260085 00382903033454

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown