BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 7060096 · Received November 27, 2017

    Report

    Report Number
    1213809-2017-00303
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    November 1, 2017
    Report Date
    January 26, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: TWO SHELF CARTONS OF SAFETYGLIDE NEEDLES FROM BATCH #6001842 WERE RECEIVED BY BD CANAAN. EACH CARTON CONTAINED 20 PACKAGED NEEDLES. MIXED PRODUCT DEFECT WAS CONFIRMED. THIS COMPLAINT WAS CONFIRMED TO BE WITHIN THE SCOPE OF A KNOWN ISSUE. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. A SITUATIONAL ANALYSIS AND CAPA EXISTS TO FURTHER INVESTIGATE. INVESTIGATION CONCLUSION: THIS COMPLAINT WAS CONFIRMED TO BE WITHIN THE SCOPE OF A KNOWN ISSUE. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. REFER TO (B)(4). NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE THAT THE CUSTOMER HAD BOX OF 25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE MIXED PRODUCT. THE PRODUCT IS 5/8 INSTEAD OF 1INCH. THE 5/8 IN WERE INDIVIDUALLY PACKAGED WITH A LABEL FOR 1 INCH NEEDLES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838950 25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 6001842 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other