BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LS 22X1-1/4 AN EMERALD

    MDR report key: 10222508 · Received July 2, 2020

    Report

    Report Number
    3002682307-2020-00206
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Date of Event
    June 10, 2020
    Report Date
    July 28, 2020
    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

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1901131 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO PICTURES SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, DAMAGE WAS OBSERVED TO THE PLUNGER COMPONENT. THE MATERIAL USED TO MANUFACTURE THE EMERALD SYRINGE HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. IT HAS BEEN DETERMINED THAT THE PLUNGER ROD DAMAGE RESULTED FROM A BLOCKAGE IN THE PRIMARY PACKAGING MACHINE FEEDER. THERE ARE SEVERAL PREVENTIVE MEASURES IN PLACE TO REDUCE THE CHANCE OF THIS DEFECT AND VARIOUS INSPECTION STEPS TO DETECT AND REJECT THIS DEFECT IF IT WERE TO OCCUR. WE BELIEVE THAT THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 5ML LS 22X1-1/4 AN EMERALD PLUNGER ROD WAS FOUND BROKEN BEFORE USE. THIS OCCURRED WITH 4 SEPARATE SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: '1. THE CUSTOMER USED THE PRODUCT ON THE EVENING OF JUNE 10TH AND FOUND THE SYRINGE¿S PLUNGER ROD AND HANDLE DEFORMED AND INCOMPLETE WHEN OPENING THE PACKAGE."

    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 THE SYRINGE 5 ML LS 22X1-1/4 AN EMERALD PLUNGER ROD WAS FOUND BROKEN BEFORE USE. THIS OCCURRED WITH 4 SEPARATE SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: '1. THE CUSTOMER USED THE PRODUCT ON THE EVENING OF JUNE 10TH AND FOUND THE SYRINGE¿S PLUNGER ROD AND HANDLE DEFORMED AND INCOMPLETE WHEN OPENING THE PACKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686438 SYRINGE 5ML LS 22X1-1/4 AN EMERALD PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1901131

    Patients

    Seq Age Sex Outcome Treatment
    1 Other