BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 15851339 · Received November 23, 2022

    Report

    Report Number
    1213809-2022-01077
    Event Type
    Malfunction
    Date Received
    November 23, 2022
    Date of Event
    October 31, 2022
    Report Date
    December 20, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL/CORRECTED INFORMATION: B3. THE INITIAL REPORTER HAS CLARIFIED THE DATE OF EVENT TO BE 31 OCTOBER 2022. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305916 AND LOT NUMBER 2024137. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT#: 2010821, MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026, DEVICE MANUFACTURE DATE: 10-JAN-2022, MEDICAL DEVICE LOT#: 2024137. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026. DEVICE MANUFACTURE DATE: 24-JAN-2022. 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 THAT AN UNSPECIFIED NUMBER OF BD SAFETYGLIDE¿ NEEDLES FROM LOTS 2010821 AND 2024137 WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS PER ACCOUNT, THE LAST 2 SHIPMENTS OF NEEDLES (308-305916) WE HAVE RECEIVED HAVE SO MANY DEFECTIVE NEEDLES PER CASE THAT THEY ARE PRACTICALLY USELESS, AT LEAST HALF THE NEEDLES ARE BEING THROWN OUT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SAFETYGLIDE¿ NEEDLES FROM LOTS: 2010821 AND 2024137 WERE BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS PER ACCOUNT, THE LAST 2 SHIPMENTS OF NEEDLES (308-305916) WE HAVE RECEIVED HAVE SO MANY DEFECTIVE NEEDLES PER CASE THAT THEY ARE PRACTICALLY USELESS, AT LEAST HALF THE NEEDLES ARE BEING THROWN OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413496 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS SEE H10 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown