BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 6885040 · Received September 21, 2017

    Report

    Report Number
    1213809-2017-00132
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    August 29, 2017
    Report Date
    December 19, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO PARTIALLY FILLED SHELF CARTONS WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCH #6001842 (P/N 305916). SAMPLE EVALUATION CONFIRMED 11 OUT OF 50 TOTAL SAMPLES FOR MIXED PRODUCT CONDITION. THE CONDITION IS CONFIRMED TO BE WITHIN THE SCOPE OF A KNOWN ISSUE. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE CONFIRMED: BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. REFER TO SITUATIONAL ANALYSIS MSS-16-800-SA AND CAPA #: (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER WAS SENT SEVERAL BOXES OF 25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE(S). UPON OPENING BOX, CUSTOMER FOUND MIXED PRODUCT, INCLUDING 1 ¿AND ½¿ NEEDLES, DUE TO INCORRECT PRODUCT LABELING. THIS WAS OBSERVED BEFORE USE WITH NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663503 25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 6001842

    Patients

    Seq Age Sex Outcome Treatment
    1 Other