BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE CONTROL 10ML LL

    MDR report key: 10590968 · Received September 26, 2020

    Report

    Report Number
    1213809-2020-00662
    Event Type
    Malfunction
    Date Received
    September 26, 2020
    Date of Event
    August 28, 2020
    Report Date
    November 4, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096955
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE PHOTO OF A LOOSE 10ML SYRINGE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A LARGE, CLEAR FOREIGN MATTER PARTICLE IN THE FLUID PATH. THE FOREIGN MATTER APPEARED TO BE A PIECE OF PLASTIC AND WAS LARGE ENOUGH IN SIZE TO BE REJECTABLE PER PRODUCT SPECIFICATION. BASED ON THE PHOTO, IT WAS UNCLEAR WHAT COMPONENT THE PLASTIC FRAGMENT CAME FROM. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0113359.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE CONTROL 10ML LL EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309695 BATCH NO.: 0113359 PHARMACY WAS DRAWING UP LOCAL ANESTHETIC IN BD 10 ML CONTROL SYRINGES. THE PHARMACY TECHNICIAN NOTICED A SMALL PIECE OF PLASTIC INSIDE ONE SYRINGE. THE SYRINGE WAS NOT BROKEN, THE ISSUE MAY HAVE HAPPENED DURING MANUFACTURING.

    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 CONTROL 10ML LL EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309695, BATCH NO.: 0113359. PHARMACY WAS DRAWING UP LOCAL ANESTHETIC IN BD 10 ML CONTROL SYRINGES. THE PHARMACY TECHNICIAN NOTICED A SMALL PIECE OF PLASTIC INSIDE ONE SYRINGE. THE SYRINGE WAS NOT BROKEN, THE ISSUE MAY HAVE HAPPENED DURING MANUFACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055672 SYRINGE CONTROL 10ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309695 0113359 30382903096955

    Patients

    Seq Age Sex Outcome Treatment
    1 Other