BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD NEEDLE

    MDR report key: 9916732 · Received April 2, 2020

    Report

    Report Number
    2243072-2020-00548
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    March 13, 2020
    Report Date
    April 15, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, MATERIAL NUMBER, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THESE TYPES OF PRODUCT MALFUNCTIONS DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED BD NEEDLE DETACHED FROM THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SINCE THE BEGINNING OF THIS WEEK (9 MARCH) THEY HAVE HAD PROBLEMS WITH OUR MICROLANCE-NEEDLES. ESPECIALLY THE GREEN (21G) BUT MAYBE ALSO BLUE (23G). NO PROBLEMS WITH ORANGE, YELLOW AND PINK. THE PROBLEM THEY HAVE IS: VERY HARD TO TAKE OFF THE PLASTIC COVER, THEY REALLY NEED TO PULL VERY MUCH TO GET IT LOOSE. THE NEEDLE DROPS OFF SOMETIMES WHEN THEY USE MEDICATION WITH HIGH VISCOSITY (HARDER TO PUSH). THEY USE THE BBRAUN OMNIFLEX-SYRINGES. THEY HAVEN´T HAD THIS ISSUE BEFORE, WHEN THEY HAVE USED OUR MICROLANCE NEEDLES. IS IT JUST THIS BATCH /LOT, OR IS IT SOMETHING NEW IN THE PRODUCTION-PROCESS? (THEY ONLY HAVE THIS LOT-NUMBER IN THE CLINIC TODAY). THEY HAVE NO USED MICROLANCE-NEEDLES TO COLLECT TODAY, BUT I HAVE ASKED THEM TO TAKE OUT 10 GREEN MICROLANCE-NEEDLES SO THAT WE CAN EVALUATE. ONE PROBLEM OCCURS BEFORE USING THE NEEDLE (TO TAKE OFF THE HAT) AND THE OTHER ONE, THAT THE NEEDLE FALLS OFF WHEN ATTACHED TO A SYRINGE, IS BETTER TO TEST BEFORE THEY PRESS IT TO FIT THE SYRINGE. THEREFORE I THINK IT IS OK TO TEST THE UNUSED NEEDLES. IF YOU WANT ME TO ASK THEM TO COLLECT USED NEEDLES, I WILL."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD NEEDLE DETACHED FROM THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SINCE THE BEGINNING OF THIS WEEK (9 MARCH) THEY HAVE HAD PROBLEMS WITH OUR MICROLANCE-NEEDLES. ESPECIALLY THE GREEN (21G) BUT MAYBE ALSO BLUE (23G). NO PROBLEMS WITH ORANGE, YELLOW AND PINK. THE PROBLEM THEY HAVE IS: VERY HARD TO TAKE OFF THE PLASTIC COVER, THEY REALLY NEED TO PULL VERY MUCH TO GET IT LOOSE. THE NEEDLE DROPS OFF SOMETIMES WHEN THEY USE MEDICATION WITH HIGH VISCOSITY (HARDER TO PUSH). THEY USE THE BBRAUN OMNIFLEX-SYRINGES. THEY HAVEN´T HAD THIS ISSUE BEFORE, WHEN THEY HAVE USED OUR MICROLANCE NEEDLES. IS IT JUST THIS BATCH /LOT, OR IS IT SOMETHING NEW IN THE PRODUCTION-PROCESS? (THEY ONLY HAVE THIS LOT-NUMBER IN THE CLINIC TODAY). THEY HAVE NO USED MICROLANCE-NEEDLES TO COLLECT TODAY, BUT I HAVE ASKED THEM TO TAKE OUT 10 GREEN MICROLANCE-NEEDLES SO THAT WE CAN EVALUATE. ONE PROBLEM OCCURS BEFORE USING THE NEEDLE (TO TAKE OFF THE HAT) AND THE OTHER ONE, THAT THE NEEDLE FALLS OFF WHEN ATTACHED TO A SYRINGE, IS BETTER TO TEST BEFORE THEY PRESS IT TO FIT THE SYRINGE. THEREFORE I THINK IT IS OK TO TEST THE UNUSED NEEDLES. IF YOU WANT ME TO ASK THEM TO COLLECT USED NEEDLES, I WILL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382613 UNSPECIFIED BD NEEDLE N/A FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other