BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE

    MDR report key: 10305948 · Received July 21, 2020

    Report

    Report Number
    1213809-2020-00473
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    July 1, 2020
    Report Date
    August 19, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095811
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: FIVE PHOTOS WERE RECEIVED AND EVALUATED. ONE PHOTO DISPLAYED THE TOP VIEW OF A BLISTER PACK FROM BATCH 9190475 (P/N 309581). TWO PHOTOS DISPLAYED A LOOSE, UNSHIELDED CANNULA NEXT TO A LOOSE 3ML SYRINGE. TWO PHOTOS DISPLAYED A 3ML SYRINGE INSIDE AN OPENED BLISTER PACK WITH A LOOSE, UNSHIELDED CANNULA NEXT TO IT. NO VISUAL DEFECTS WERE OBSERVED IN ANY OF THE PHOTOS RECEIVED. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE PHOTOS AND NO CORRECTIVE ACTIONS ARE NOT REQUIRED AT THIS TIME. DHR WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE "POPPED OFF" THE BD SYRINGE LUER-LOK¿ TIP AND "FLEW ACROSS THE ROOM" WHEN PUSHING AIR THROUGH THE PLUNGER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I INJECT FOLIC ACID DAILY, AND HAVE DONE SO FOR THE PAST YEAR, ALWAYS USING BD SYRINGES AND ALCOHOL WIPES. I ALWAYS PULL, THEN PUSH AIR THROUGH THE SYRINGE. TODAY, WHEN I DID THAT, AS I PUSHED THE AIR THE PLUNGER, A NEEDLE POPPED RIGHT OFF, AND FLEW ACROSS THE ROOM SOMEWHERE. I DIDN'T SEE WHERE IT WENT. I SEARCHED AND FOUND IT ON THE FLOOR. I THOUGHT I WAS DOING WELL WITH SELF INJECTING (I USE IT BECAUSE I'M ON METHOTREXATE. MY VISION IS AFFECTING MY ABILITY TO SEE THINGS LIKE SYRINGES. I'M VERY DISAPPOINTED WITH THIS INCIDENT. THE NEEDLE COULD HAVE GOTTEN STUCK IN MY LEG. LOOKING THROUGH MY 60 DAY SUPPLY, THE LOT NUMBERS ARE ALL THE SAME."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE "POPPED OFF" THE BD SYRINGE LUER-LOK¿ TIP AND "FLEW ACROSS THE ROOM" WHEN PUSHING AIR THROUGH THE PLUNGER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I INJECT FOLIC ACID DAILY, AND HAVE DONE SO FOR THE PAST YEAR, ALWAYS USING BD SYRINGES AND ALCOHOL WIPES. I ALWAYS PULL, THEN PUSH AIR THROUGH THE SYRINGE. TODAY, WHEN I DID THAT, AS I PUSHED THE AIR THE PLUNGER, A NEEDLE POPPED RIGHT OFF, AND FLEW ACROSS THE ROOM SOMEWHERE. I DIDN'T SEE WHERE IT WENT. I SEARCHED AND FOUND IT ON THE FLOOR. I THOUGHT I WAS DOING WELL WITH SELF INJECTING (I USE IT BECAUSE I'M ON METHOTREXATE.) MY VISION IS AFFECTING MY ABILITY TO SEE THINGS LIKE SYRINGES. I'M VERY DISAPPOINTED WITH THIS INCIDENT. THE NEEDLE COULD HAVE GOTTEN STUCK IN MY LEG. LOOKING THROUGH MY 60 DAY SUPPLY, THE LOT NUMBERS ARE ALL THE SAME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770219 BD SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309581 9190475 30382903095811

    Patients

    Seq Age Sex Outcome Treatment
    1 Other