BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS SP120

    MDR report key: 12242750 · Received July 28, 2021

    Report

    Report Number
    3003152976-2021-00432
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    June 29, 2021
    Report Date
    September 13, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWENTY TWO SAMPLES AND PHOTOS RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION OF THE SAMPLES RECEIVED, NO MOLDING OR OTHER DEFECT CAN BE NOTICED IN THE SYRINGE, NO BURRS OR DEFORMATIONS CAN BE SEEN IN THE TIP. ADDITIONALLY, TEN RETAINED SAMPLES OF LOT 200612 WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS IDENTIFIED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2006012, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1ML LS SP120 WAS DIFFICULT TO CONNECT TO THE TFK LABORATORY NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THIS IS A REPORT ABOUT SYRINGE NEEDLE CONNECTIVITY ISSUE. THE CUSTOMER USES THIS PRODUCT FOR COVID VACCINATION." "THE CONNECTION OF THIS SYRINGE (CAT#303172) TO TSK LABORATORY¿S NEEDLE BECAME LOOSE IN 20 OF 320 PRODUCTS."

    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 THE SYRINGE 1ML LS SP120 WAS DIFFICULT TO CONNECT TO THE TFK LABORATORY NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THIS IS A REPORT ABOUT SYRINGE NEEDLE CONNECTIVITY ISSUE. THE CUSTOMER USES THIS PRODUCT FOR COVID VACCINATION." "THE CONNECTION OF THIS SYRINGE (CAT#303172) TO TSK LABORATORY¿S NEEDLE BECAME LOOSE IN 20 OF 320 PRODUCTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137110 SYRINGE 1ML LS SP120 PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2006012

    Patients

    Seq Age Sex Outcome Treatment
    1