BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20 ML SYRINGE WITH NEEDLE

    MDR report key: 8800870 · Received July 17, 2019

    Report

    Report Number
    3002682307-2019-00409
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    July 3, 2019
    Report Date
    August 1, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS BEEN PROVIDED WITH A PHOTO AND A SAMPLE FOR CATALOG 301948 LOT 1801214 TO INVESTIGATE FOR THIS RECORD. VISUAL INSPECTION OF THE PHOTO AND RETURNED SAMPLE IDENTIFIED A HAIR BETWEEN INSIDE THE SYRINGE, OUTSIDE THE FLUID PATH. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE.THE HAIR WAS LOST MOST LIKELY DUE TO A FAILURE TO PERFORM ANY PRACTICE OF GMP, OR NEGLECT, AS PART OF SOME RAW MATERIALS. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD¿ 20 ML SYRINGE WITH NEEDLE THERE WAS FOREIGN MATTER IN THE BARREL OF THE SYRINGE. THE PRODUCT WAS NOT USED. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT¿S NOTICED THAT FOREIGN MATTER IN THE BARREL AFTER UNWRAPPED THE PACKAGE DEFECTED PRODUCT WAS NOT USED.

    Additional Manufacturer Narrative · 1

    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 BEFORE USE OF THE BD¿ 20 ML SYRINGE WITH NEEDLE THERE WAS FOREIGN MATTER IN THE BARREL OF THE SYRINGE. THE PRODUCT WAS NOT USED. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IT¿S NOTICED THAT FOREIGN MATTER IN THE BARREL AFTER UNWRAPPED THE PACKAGE DEFECTED PRODUCT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594654 BD 20 ML SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1801214

    Patients

    Seq Age Sex Outcome Treatment
    1 Other