BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LS 21X1-1/2 AN EMERALD

    MDR report key: 8857322 · Received August 2, 2019

    Report

    Report Number
    3002682307-2019-00433
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 10, 2019
    Report Date
    September 10, 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
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH A SAMPLE FOR CATALOG: 307737, LOT: 1903331 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE SAMPLE, THE SLIDING FORCE TO GLIDE THE PLUNGER ROD WAS FOUND CORRECT. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. BASED ON OUR MANUFACTURING RECORDS, BD CAN STATE THAT THE SYRINGES REPORTED MEET THE PRODUCT SPECS AND RECOMMENDED VALUES IN THE PRODUCT STANDARDS. ON THE OTHER HAND, EITHER THE MEDICATION/DRUG USED BY THE CUSTOMER OR A SPECIAL METHOD OF USE (HIGH TEMPERATURES, PRESSURES, SEVERAL USES, ETC.) COULD AFFECT THE SLIDING PROPERTIES OF THE SYRINGES. REVIEW OF SYRINGE DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT. CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. H3 OTHER TEXT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML LS 21X1-1/2 AN EMERALD EXPERIENCED A FAILURE TO CONTAIN BLOOD/MEDICATION, DIFFICULT PLUNGER MOVEMENT, OR STOPPER SEPARATION FROM PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DOCTOR HAS PURCHASED A LARGE QUANTITY OF EMERALD SYRINGES 5ML AND 10 ML WITH NEEDLE, AND HAS FACED MAJOR DIFFICULTY DRAWING BACK THE PLUNGER , AS IT LOOKS LIKE MANY OF THE GREEN RUBBER STOPPERS ARE DISPLACED INSIDE THE SYRINGE.

    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 AN UNSPECIFIED NUMBER OF SYRINGE 10ML LS 21X1-1/2 AN EMERALD EXPERIENCED A FAILURE TO CONTAIN BLOOD/MEDICATION, DIFFICULT PLUNGER MOVEMENT, OR STOPPER SEPARATION FROM PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DOCTOR HAS PURCHASED A LARGE QUANTITY OF EMERALD SYRINGES 5ML AND 10 ML WITH NEEDLE, AND HAS FACED MAJOR DIFFICULTY DRAWING BACK THE PLUNGER , AS IT LOOKS LIKE MANY OF THE GREEN RUBBER STOPPERS ARE DISPLACED INSIDE THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647765 SYRINGE 10ML LS 21X1-1/2 AN EMERALD SYRINGE FMF BECTON DICKINSON, S.A. 1903331

    Patients

    Seq Age Sex Outcome Treatment
    1 Other