BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20 ML SYRINGE WITH NEEDLE

    MDR report key: 10989146 · Received December 10, 2020

    Report

    Report Number
    3002682307-2020-00399
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 15, 2020
    Report Date
    March 17, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1811162. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, PRINTING FOIL PARTICLES WERE OBSERVED STUCK TO THE BARREL WALL OF THE SYRINGE. THE PROCESS USED TO PRINT THE SCALE ONTO THE DISCARDIT SYRINGES IS CALLED ¿HOT STAMPING.¿ A HEATED METAL STAMP IS USED TO TRANSFER THE PRINTING FOIL ONTO THE BARREL WALL. THIS IS A HIGHLY CAPABLE PROCESS; HOWEVER, IN SOME CASES THERE IS A POSSIBILITY THAT SOME MINOR FOIL SPECKS COULD BECAME ATTACHED TO THE EXTERNAL SURFACE OF THE BARREL. THE PRESENCE OF INK SPECKS SHOULD BE VERY LIMITED AND THE RISK ASSOCIATED WITH THIS ISSUE SHOULD BE VERY LOW TO NEGLIGIBLE, AS IT SHOULD NOT REPRESENT ANY IMPACT TO THE HEALTH OF THE PATIENT OR THE USER. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2,080 BD¿ 20 ML SYRINGES WITH NEEDLES EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE IN THE GENERAL WARD FOUND BLACK FLOCCULES IN THE UNOPENED 20ML SYRINGE WHEN DISPENSING THE LIQUID.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2,080 BD¿ 20 ML SYRINGES WITH NEEDLES EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE IN THE GENERAL WARD FOUND BLACK FLOCCULES IN THE UNOPENED 20ML SYRINGE WHEN DISPENSING THE LIQUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446222 BD 20 ML SYRINGE WITH NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1811162

    Patients

    Seq Age Sex Outcome Treatment
    1