BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD SYRINGE WITH LUER-SLIP TIP AND PRE-ATTACHED NEEDLE

    MDR report key: 9286410 · Received November 6, 2019

    Report

    Report Number
    3002682307-2019-00597
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 7, 2019
    Report Date
    November 26, 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

    INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH A SAMPLE FOR CATALOG 307737 LOT 1904119 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE SAMPLE PRESENTED A BROKEN HUB AT THE LEVEL OF THE MIDDLE HUB. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. AFTER THE SAMPLE EVALUATION AND AFTER DISCUSSING WITH OUR PRODUCTION TECHNICIANS, THE ISSUE MAY BE PRODUCED IN THE TRAY OF THE HUB FEEDER WHERE HUBS ARE PLACED IN RACKS (A PLASTIC PIECE USED TO MOVE NEEDLES THOUGH THE ASSEMBLED PROCESS). IF ANY HUB HAS SOME INAPPROPRIATE PLACEMENT DUE TO SOME UNEXPECTED MOVEMENT, IT COULD HAVE BEEN ENOUGH DAMAGED TO BREAK ITSELF DURING HANDLING OF THE PRODUCT. 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. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. CONCLUSION: A COMBINATION OF MANUFACTURING ISSUE (MAY BE PRODUCED IN THE TRAY OF THE HUB FEEDER WHERE IF ANY HUB HAS SOME INAPPROPRIATE PLACEMENT DUE TO SOME UNEXPECTED MOVEMENT, IT COULD HAVE BEEN ENOUGH DAMAGED) AND AN INCORRECT HANDLING WHICH PROVOKE HUB BREAKS ITSELF DURING HANDLING.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD EMERALD¿ SYRINGE WITH LUER-SLIP TIP AND PRE-ATTACHED NEEDLE HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED AN INFORMATIVE EMAIL FROM THE END USER REPORTING THAT THERE WAS A DEFECT ON THE SYRINGE REF 307737 EMERALD 10ML . APPARENTLY THE GREEN PLASTIC PART THAT CONNECTS THE NEEDLE WITH THE SYRINGE WAS BROKEN AND THERE WAS A LEAKAGE OF BLOOD OUT THE SYRINGE DURING BLOOD SAMPLING. THERE WAS A COMMENT OF THE CLIENT THAT IT WAS THE 4TH CASE OF DEFECTED SYRINGE WITHIN THIS YEAR.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD EMERALD¿ SYRINGE WITH LUER-SLIP TIP AND PRE-ATTACHED NEEDLE HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED AN INFORMATIVE EMAIL FROM THE END USER REPORTING THAT THERE WAS A DEFECT ON THE SYRINGE REF 307737 EMERALD 10ML . APPARENTLY THE GREEN PLASTIC PART THAT CONNECTS THE NEEDLE WITH THE SYRINGE WAS BROKEN AND THERE WAS A LEAKAGE OF BLOOD OUT THE SYRINGE DURING BLOOD SAMPLING. THERE WAS A COMMENT OF THE CLIENT THAT IT WAS THE 4TH CASE OF DEFECTED SYRINGE WITHIN THIS YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077561 BD EMERALD SYRINGE WITH LUER-SLIP TIP AND PRE-ATTACHED NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1904119

    Patients

    Seq Age Sex Outcome Treatment
    1 Other