BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    MDR report key: 7643184 · Received June 27, 2018

    Report

    Report Number
    9616656-2018-00126
    Event Type
    Injury
    Date Received
    June 27, 2018
    Date of Event
    May 28, 2018
    Report Date
    August 27, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ACTIVATION TESTING WAS CARRIED OUT ON THE 6 RETURNED SAMPLES FROM LOT 7229888 AND 24 SAMPLES FROM LOT 7172630 AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE STICK INJURY OCCURRED FROM A BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE AFTER A PATIENT PUNCTURE DUE TO THE SAFETY MECHANISM NOT PASSIVELY ACTIVATING. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE STICK INJURY OCCURRED FROM A BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE AFTER A PATIENT PUNCTURE DUE TO THE SAFETY MECHANISM NOT PASSIVELY ACTIVATING. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7172630; MEDICAL DEVICE EXPIRATION DATE: 2020-07-31; DEVICE MANUFACTURE DATE: 2017-06-21; MEDICAL DEVICE LOT #: 7229888; MEDICAL DEVICE EXPIRATION DATE: 2020-09-30; DEVICE MANUFACTURE DATE: 2017-08-17. 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 THAT A NEEDLE STICK INJURY OCCURRED FROM A BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE AFTER A PATIENT PUNCTURE DUE TO THE SAFETY MECHANISM NOT PASSIVELY ACTIVATING. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485742 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other