BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 25X1 RB

    MDR report key: 10457938 · Received August 26, 2020

    Report

    Report Number
    1213809-2020-00577
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    August 6, 2020
    Report Date
    September 24, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT NEEDLE SFTYGLD 25X1 RB HAD CLOGGED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT: AFTER MEDICATION KENALOG IS DRAWN AT THE 1/2 MARK THE PLUNGER DOES NOT MOVE, IT STOPS COMPLETELY. EVENT DESCRIPTION STATES: I HAVE RAN INTO THE 25G X 1 BD SAFETY GLIDE NEEDLE LOT #9232455 STICKING IN PLACE. WHEN I GO TO GIVE A SHOT IT INJECTS UP TO ½ MARK AND THEN STOPS. IT WILL NOT MOVE AT ALL. I THEN TAKE IT OUT OF THE PT AND TRY PUSHING THE PLUNGER AND IT STILL WONT WORK. THIS HAS HAPPENED TWICE NOW. I TAKE OFF THE ORIGINAL NEEDLE AFTER DRAWING UP THE MEDICATION. IT HAS NEVER MALFUNCTIONED WHEN GIVING VACCINATIONS. IT HAS MALFUNCTIONED TWICE WHEN GIVING KENALOG WHICH IS A THICKER MEDICATION. IT HAS WORKED MULTIPLE TIMES WITH THE SAME MEDICATION. I DON'T KNOW IF IT'S THE NEEDLE OR THE SYRINGE. IM PRETTY SURE IT'S THE SYRINGE. QUESTIONS/INQUIRIES: COMPLAINT RATIONALE: BASED ON THE INFORMATION PROVIDED, OUR CONCLUSION IS THAT THE DEVICE CITED MEETS OUR CRITERIA OF A COMPLAINT ¿ APPENDIX 1 - COMPLAINT DETERMINATION TREE ¿ ((B)(4))"

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO OF A LOOSE SAFETYGLIDE NEEDLE ASSEMBLY ON TOP OF AN OPENED BLISTER PACK AND 3ML SYRINGE WITH NEEDLE ATTACHED INSIDE A FULLY SEALED BLISTER WAS RECEIVED AND EVALUATED. THE CLOGGED NEEDLE DEFECT COULD NOT BE CONFIRMED FROM THE PHOTO. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. ALL VISUAL INSPECTIONS FOR BATCH 9232455 WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. THE BATCH WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE SFTYGLD 25X1 RB HAD CLOGGED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT: AFTER MEDICATION KENALOG IS DRAWN AT THE 1/2 MARK THE PLUNGER DOES NOT MOVE, IT STOPS COMPLETELY. EVENT DESCRIPTION STATES: I HAVE RAN INTO THE 25G X 1 BD SAFETY GLIDE NEEDLE LOT #9232455 STICKING IN PLACE. WHEN I GO TO GIVE A SHOT IT INJECTS UP TO ½ MARK AND THEN STOPS. IT WILL NOT MOVE AT ALL. I THEN TAKE IT OUT OF THE PT AND TRY PUSHING THE PLUNGER AND IT STILL WONT WORK. THIS HAS HAPPENED TWICE NOW. I TAKE OFF THE ORIGINAL NEEDLE AFTER DRAWING UP THE MEDICATION. IT HAS NEVER MALFUNCTIONED WHEN GIVING VACCINATIONS. IT HAS MALFUNCTIONED TWICE WHEN GIVING KENALOG WHICH IS A THICKER MEDICATION. IT HAS WORKED MULTIPLE TIMES WITH THE SAME MEDICATION. I DON'T KNOW IF IT'S THE NEEDLE OR THE SYRINGE. IM PRETTY SURE IT'S THE SYRINGE. QUESTIONS/INQUIRIES: COMPLAINT RATIONALE: BASED ON THE INFORMATION PROVIDED, OUR CONCLUSION IS THAT THE DEVICE CITED MEETS OUR CRITERIA OF A COMPLAINT ¿ APPENDIX 1 - COMPLAINT DETERMINATION TREE ¿ ((B)(4))".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE SFTYGLD 25X1 RB WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT: AFTER MEDICATION KENALOG IS DRAWN AT THE 1/2 MARK THE PLUNGER DOES NOT MOVE, IT STOPS COMPLETELY. EVENT DESCRIPTION STATES: I HAVE RAN INTO THE 25G X 1 BD SAFETY GLIDE NEEDLE LOT #9232455 STICKING IN PLACE. WHEN I GO TO GIVE A SHOT IT INJECTS UP TO ½ MARK AND THEN STOPS. IT WILL NOT MOVE AT ALL. I THEN TAKE IT OUT OF THE PT AND TRY PUSHING THE PLUNGER AND IT STILL WONT WORK. THIS HAS HAPPENED TWICE NOW. I TAKE OFF THE ORIGINAL NEEDLE AFTER DRAWING UP THE MEDICATION. IT HAS NEVER MALFUNCTIONED WHEN GIVING VACCINATIONS. IT HAS MALFUNCTIONED TWICE WHEN GIVING KENALOG WHICH IS A THICKER MEDICATION. IT HAS WORKED MULTIPLE TIMES WITH THE SAME MEDICATION. I DON'T KNOW IF IT'S THE NEEDLE OR THE SYRINGE. IM PRETTY SURE IT'S THE SYRINGE. QUESTIONS/INQUIRIES: COMPLAINT RATIONALE: BASED ON THE INFORMATION PROVIDED, OUR CONCLUSION IS THAT THE DEVICE CITED MEETS OUR CRITERIA OF A COMPLAINT ¿ APPENDIX 1 - COMPLAINT DETERMINATION TREE ¿ ((B)(4))".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE SFTYGLD 25X1 RB WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT: AFTER MEDICATION KENALOG IS DRAWN AT THE 1/2 MARK THE PLUNGER DOES NOT MOVE, IT STOPS COMPLETELY. EVENT DESCRIPTION STATES: I HAVE RAN INTO THE 25G X 1 BD SAFETY GLIDE NEEDLE LOT #9232455 STICKING IN PLACE. WHEN I GO TO GIVE A SHOT IT INJECTS UP TO ½ MARK AND THEN STOPS. IT WILL NOT MOVE AT ALL. I THEN TAKE IT OUT OF THE PT AND TRY PUSHING THE PLUNGER AND IT STILL WONT WORK. THIS HAS HAPPENED TWICE NOW. I TAKE OFF THE ORIGINAL NEEDLE AFTER DRAWING UP THE MEDICATION. IT HAS NEVER MALFUNCTIONED WHEN GIVING VACCINATIONS. IT HAS MALFUNCTIONED TWICE WHEN GIVING KENALOG WHICH IS A THICKER MEDICATION. IT HAS WORKED MULTIPLE TIMES WITH THE SAME MEDICATION. I DON'T KNOW IF IT'S THE NEEDLE OR THE SYRINGE. IM PRETTY SURE IT'S THE SYRINGE. QUESTIONS/INQUIRIES: COMPLAINT RATIONALE: BASED ON THE INFORMATION PROVIDED, OUR CONCLUSION IS THAT THE DEVICE CITED MEETS OUR CRITERIA OF A COMPLAINT ¿ APPENDIX 1 - COMPLAINT DETERMINATION TREE ¿ (B)(4)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922393 NEEDLE SFTYGLD 25X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305916 9232455 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other