BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1911916-2018-00344

    MDR report key: 7647621 · Received June 28, 2018

    Report

    Report Number
    1911916-2018-00344
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    June 7, 2018
    Report Date
    August 1, 2018
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE PROVIDED FOR EVALUATION THEREFORE FAILURE MODE WAS NOT VERIFIED. THE COMPONENTS HAVE BEEN RETURNED AND EVALUATED BY REGENERON QUALITY ANALYST: NO FOREIGN MATTER / NO HAIR WAS OBSERVED ON THE INJECTION NEEDLE OR INSIDE THE INJECTION NEEDLE SHIELD. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND REGARDING FOREIGN MATTER. THE DHR REVIEW WAS PERFORMED ON ASSEMBLY BATCH 6299682. WITH THE EXCEPTION OF THE OUT OF SPEC. LUBE SOLIDS, ALL PRODUCT WAS WITHIN SPECIFICATION. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FOREIGN MATTER WITH LOT #6339772 REGARDING ITEM (B)(4). ROOT CAUSE IS UNDETERMINED. THE DEFECT COULD NOT BE CONFIRMED AS REPORTED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HAIR WAS FOUND ON THE HUB OF A BD PRECISIONGLIDE SPECIALTY USE STERILE HYPODERMIC NEEDLE PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER FACILITY NAME: (B)(6). 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 HAIR WAS FOUND ON THE HUB OF A BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other