BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO-DISABLE SYRINGE, 0.5ML BD SOLOSHOT¿ IX

    MDR report key: 13430302 · Received February 2, 2022

    Report

    Report Number
    3002682307-2022-00035
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 17, 2022
    Report Date
    March 7, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306398 AND LOT NUMBER 2106463. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, FOUR PICTURE SAMPLES AND THREE AFFECTED PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. EACH OF THE PHYSICAL SAMPLES HAD THE CLIP ALREADY ACTIVATED. ONE OF THE SYRINGES DISPLAYED A CANNULA POINT WHICH WAS NOT WELL FORMED (NEEDLE BIFURCATED). THE PICTURES PROVIDED ALSO SHOW A NOT WELL-FORMED CANNULA POINT AS WELL AS A SYRINGE WITH A BROKEN PLUNGER. IN REGARDS TO THE CANNULA DAMAGE, THE MANUFACTURING PLANT IS PROVIDED WITH CLOSED CARTRIDGES OF CANNULAS WHICH ARE DIRECTLY INTRODUCED INTO THE ASSEMBLY MACHINE. AFTERWARDS, AN INLINE CAMERA SYSTEM INSPECTS ALL NEEDLE POINTS AND REJECTS ANY DEFECTS IDENTIFIED. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING AUTO-DISABLE SYRINGE, 0.5ML BD SOLOSHOT¿ IX A NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE BIFURCATED, SHARPNESS OF THE NEEDLE IS AN ISSUE AS WELL, IT RELEASE AIR BUBBLE INTO THE VIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING AUTO-DISABLE SYRINGE, 0.5ML BD SOLOSHOT¿ IX A NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE BIFURCATED, SHARPNESS OF THE NEEDLE IS AN ISSUE AS WELL, IT RELEASE AIR BUBBLE INTO THE VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779059 AUTO-DISABLE SYRINGE, 0.5ML BD SOLOSHOT¿ IX PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2106463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown