BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO-DISABLE SYRINGE, 0.5ML BD SOLOSHOT¿ IX

    MDR report key: 13430299 · Received February 2, 2022

    Report

    Report Number
    3002682307-2022-00036
    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. REGARDING THE DEFECTS OF BROKEN PLUNGER AND LOCKED SYRINGES PRIOR TO USE, WE UNDERSTAND THAT A MALFUNCTION WITH THE CLIP ASSEMBLY COULD HAVE TAKEN PLACE. DURING THE CLIP ASSEMBLY, IT IS POSSIBLE FOR THE CLIP TO BE MISPLACED AND ACTIVATED, WHICH WOULD CAUSE THE SYRINGE TO BE IMPOSSIBLE TO USE. H3 OTHER TEXT : SEE H.10.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING AUTO-DISABLE SYRINGE, 0.5ML BD SOLOSHOT¿ IX A PLUNGER WAS DIFFICULT TO MOVE THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOCKED SYRINGES BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING AUTO-DISABLE SYRINGE, 0.5ML BD SOLOSHOT¿ IX A PLUNGER WAS DIFFICULT TO MOVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOCKED SYRINGES BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING AUTO-DISABLE SYRINGE, 0.5ML BD SOLOSHOT¿ IX A PLUNGER WAS DIFFICULT TO MOVE THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOCKED SYRINGES BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779056 AUTO-DISABLE SYRINGE, 0.5ML BD SOLOSHOT¿ IX PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2106463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown