BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE 25 G X 1 IN.

    MDR report key: 6829057 · Received August 29, 2017

    Report

    Report Number
    1213809-2017-00086
    Event Type
    Malfunction
    Date Received
    August 29, 2017
    Date of Event
    August 8, 2017
    Report Date
    December 7, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A TOTAL OF 11 SEALED SAMPLES AND 2 OPENED PACKAGES WITH NO PRODUCT WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #6001842 (P/N 305916). VISUAL EVALUATION CONFIRMED 6 OF THE SEALED SAMPLES WITH CORRECT 1" NEEDLE LENGTH AND 5 OF THE SEALED SAMPLES WITH INCORRECT SHORTER NEEDLE LENGTH THAN SPECIFIED FOR THIS PRODUCT. THIS COMPLAINT IS CONFIRMED TO BE WITHIN THE SCOPE OF A KNOWN ISSUE. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. NO FURTHER ACTION IS REQUIRED AT THIS TIME. BASED ON SAMPLE THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. SITUATIONAL ANALYSIS (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. REFER TO CRS # (B)(4), SITUATIONAL ANALYSIS (B)(4) AND CAPA # (B)(4). NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER OPENING A LABELED BOX OF BD SAFETYGLIDE¿ NEEDLE 25 G X 1 IN., ONLY 5/8¿ NEEDLES WERE FOUND INSIDE. THIS BOX OF NEEDLES WAS MIS-LABELED, WHILE IT SHOULD HAVE CONTAINED IM NEEDLES, THE ONES FOUND PACKAGED WERE SC. THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606360 BD SAFETYGLIDE¿ NEEDLE 25 G X 1 IN. NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 6001842

    Patients

    Seq Age Sex Outcome Treatment
    1 Other