BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE II SHORT NEEDLE INSULIN SYRINGE

    MDR report key: 9166649 · Received October 8, 2019

    Report

    Report Number
    1920898-2019-01102
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    September 23, 2019
    Report Date
    October 10, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (10) 1CC, 8MM, 30G SYRINGES IN A SEALED POLY BAG FROM LOT # 7240673. CUSTOMER STATES THAT HER FINGER WAS PRICKED BY A NEEDLE WHICH WAS UNCAPPED, THE SHARP END OF THE NEEDLE PROTRUDING OUT FROM THE PACK. THE RETURNED POLY BAG WAS EXAMINED AND EXHIBITED ONE SYRINGE WITH THE SHIELD OFF IN THE BAG AND THE CANNULA EXPOSED, WHICH CAUSE A NEEDLE STICK. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240673. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200713528] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. VISUAL INSPECTION OF THE PHOTOS FOUND (1) SYRINGE WITH SHIELD MISSING AND THE CANNULA PIERCED THROUGH THE POLYBAG. THE CANNULA IS NOT BENT. THE POLYBAG SHOWS MINOR IMPACT DAMAGE. REVIEW OF QUALITY NOTIFICATIONS FOUND NO NOTIFICATIONS RELATED TO THE COMPLAINT. THE AUTOPACKOUT SYSTEM RECEIVES BAGS OF SYRINGES FROM THE FF&S MACHINE. THE EQUIPMENT ERECTS THE CARTON AND LOADS THE APPROPRIATE AMOUNT OF BAGS OF SYRINGES INTO THE CARTON. THE CARTONS ARE CLOSED BEFORE BEING PLACED ON THE OUTFEED CONVEYOR. UNABLE TO DETERMINE ROOT CAUSE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE AS A RETAIL ASSISTANT WAS TIDING UP A DRAWER SHE WAS PRICKED BY A NEEDLE THAT WAS UNCAPPED IN THE PACKAGE. RETAIL ASSISTANT WENT TO A&E FOR BLOOD TEST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RETAIL ASSISTANT WAS DOING HER ROUTINE STOCK CHECKS & REPLENISHMENT OF THE INSULIN NEEDLES. SHE NOTICED A PACK OF INSULIN NEEDLES LEFT LYING OUTSIDE THE INSULIN DRAWERS SO SHE WENT ON TO TIDY THE DRAWERS AND TOOK THE PACK OF INSULIN NEEDLE, ATTEMPTING TO PUT IT BACK INTO ITS DRAWER. WHEN SHE TOOK UP THE PACK OF NEEDLES, SHE WAS PRICKED AT HER RIGHT MIDDLE FINGER, BY A BD INSULIN NEEDLE WHICH WAS UNCAPPED, THE SHARP END OF THE NEEDLE PROTRUDING OUT FROM THE PACK. SHE IMMEDIATELY REPORTED TO THE MATTER TO THE REPORTING MANAGER. THE NEEDLE PACK WAS INTACT BUT THE CAP FOR THE NEEDLE HAD BEEN REMOVED. IN THIS CASE, SINCE THE PACKET OF NEEDLES WAS LYING OUTSIDE OF ITS USUAL LOCATION, CUSTOMER FOUL PLAY IS SUSPECTED. AS PER NEEDLE STICK INJURY SOP, AREA MANAGER, WAS IMMEDIATELY INFORMED & THE RETAIL ASSISTANT PROCEEDED TO A&E FOR BLOOD TESTS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE AS A RETAIL ASSISTANT WAS TIDING UP A DRAWER SHE WAS PRICKED BY A NEEDLE THAT WAS UNCAPPED IN THE PACKAGE. RETAIL ASSISTANT WENT TO A&E FOR BLOOD TEST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RETAIL ASSISTANT WAS DOING HER ROUTINE STOCK CHECKS & REPLENISHMENT OF THE INSULIN NEEDLES. SHE NOTICED A PACK OF INSULIN NEEDLES LEFT LYING OUTSIDE THE INSULIN DRAWERS SO SHE WENT ON TO TIDY THE DRAWERS AND TOOK THE PACK OF INSULIN NEEDLE, ATTEMPTING TO PUT IT BACK INTO ITS DRAWER. WHEN SHE TOOK UP THE PACK OF NEEDLES, SHE WAS PRICKED AT HER RIGHT MIDDLE FINGER, BY A BD INSULIN NEEDLE WHICH WAS UNCAPPED, THE SHARP END OF THE NEEDLE PROTRUDING OUT FROM THE PACK. SHE IMMEDIATELY REPORTED TO THE MATTER TO THE REPORTING MANAGER. THE NEEDLE PACK WAS INTACT BUT THE CAP FOR THE NEEDLE HAD BEEN REMOVED. IN THIS CASE, SINCE THE PACKET OF NEEDLES WAS LYING OUTSIDE OF ITS USUAL LOCATION, CUSTOMER FOUL PLAY IS SUSPECTED. AS PER NEEDLE STICK INJURY SOP, AREA MANAGER, WAS IMMEDIATELY INFORMED & THE RETAIL ASSISTANT PROCEEDED TO A&E FOR BLOOD TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963620 BD ULTRA-FINE II SHORT NEEDLE INSULIN SYRINGE SYRINGE FMF BD MEDICAL - DIABETES CARE 7240673

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention