BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERALD SYRINGE 5ML 24X1 AN

    MDR report key: 10946119 · Received December 4, 2020

    Report

    Report Number
    3002682307-2020-00387
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 9, 2020
    Report Date
    December 25, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO CUSTOMER RETURN SAMPLE, OR PHOTOGRAPH AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0212533. THIS IS THE FIRST COMPLAINT REPORTED ON MATERIAL NUMBER 307757 OF BATCH NUMBER 0212533. INVESTIGATION DONE ON RETAINED SAMPLES OF 0212533. AS THE ORIGINAL SAMPLE IS NOT AVAILABLE THE COMPLAINT IS UNCONFIRMED. THE INVESTIGATING TEAM TRIED TO SIMULATE THE DEFECT ON THE RETENTION SAMPLE OF 0212533 AND FOUND THAT THE DEFECT COULD BE CAUSED IF NOT PROPERLY STORED UNDER NORMAL CONDITION OF ROOM TEMPERATURE AND HUMIDITY AND AWAY FROM SUNLIGHT. WHEN THE PRODUCT IS STORED FOR A LONG TIME ON SHELF THE NEEDLE HUB IS FOUND TO GET LOOSENED WITH THE PASSAGE OF TIME. THE EXACT ROOT CAUSE REQUIRES THE ORIGINAL SAMPLE FOR INVESTIGATION. THE PROBABLE ROOT CAUSE LOOKS TO BE A STORAGE ISSUE H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HUB PULLED OUT OF THE EMERALD SYRINGE 5ML 24X1 AN AND REMAINED IN THE PATIENT'S VEIN. THIS OCCURRED 10 TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AT THE TIME OF TAKING SAMPLE NEEDLE DETACHMENT OCCURS IN MANY SYRINGES. SOME TIMES NEEDLE EVEN REMAINS IN VEIN OF PATIENT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE REPORTED LOT # [0212533] WAS NOT FOUND FOR THE REPORTED CATALOG # [307757]. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE HUB PULLED OUT OF THE EMERALD SYRINGE 5ML 24X1 AN AND REMAINED IN THE PATIENT'S VEIN. THIS OCCURRED 10 TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AT THE TIME OF TAKING SAMPLE NEEDLE DETACHMENT OCCURS IN MANY SYRINGES. SOME TIMES NEEDLE EVEN REMAINS IN VEIN OF PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413746 EMERALD SYRINGE 5ML 24X1 AN PISTON SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1