BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS SP120

    MDR report key: 12625451 · Received October 13, 2021

    Report

    Report Number
    3003152976-2021-00684
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    September 14, 2021
    Report Date
    November 5, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION OF THE PICTURES PROVIDED, IN ONE PICTURE IT CAN BE OBSERVED THERE IS A SYRINGE WITH THE STOPPER NOT CORRECTLY ASSEMBLED, ADDITIONALLY THE SECOND PHOTO SHOWS FOREIGN MATTER INSIDE THE SYRINGE. THIS FOREIGN MATTER NOTICED IS TRANSPARENT PLASTIC THAT IS BLOCKING THE TIP OF THE SYRINGE. THE TIP OF THE SYRINGE IS NOT CORRECTLY MOLDED AND THE FOREIGN MATTER NOTICED BY CUSTOMER IS A CONSEQUENCE OF THE INCORRECT MOLDING OF THE TIP. POSSIBLE ROOT CAUSE FOR FOREIGN MATTER IS ASSOCIATED WITH THE MOLDING PROCESS. POSSIBLE ROOT CAUSE FOR JAMMED STOPPER IS RELATED WITH A MISALIGNMENT OF PLUNGER-STOPPER-BARREL IN THE ASSEMBLY STATION. DHR FROM LOT 2102021 WAS REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. DHR FROM LOT 2105074 WAS REVIEWED AND ANNOTATION REGARDING BARREL MOLDING WAS FOUND IN DHR. CAVITY Nº49 OF THE MOLD S-27 WAS CANCELLED DUE TO A PIN THAT WAS TAKEN OFF DURING MANUFACTURING OF THIS LOT. PINS IN MOLDS ARE USED TO GIVE A CARNATION GEOMETRY TO PARTS. ACCORDING TO THE PICTURE RECEIVED AND THE ANNOTATION FOUND IN THE DHR, THE ROOT CAUSE OF THE ALLEGED DEFECT IS RELATED TO THE TAKEN OFF PIN WITH HIGH PROBABILITY. IF A PIN IS TAKEN OFF, THE INNER GEOMETRY OF THE SYRINGE IS NOT CORRECTLY MANUFACTURED AND THE TIP OF THE SYRINGE IS NOT MOLDED PROPERLY, LEAVING ADDITIONAL PLASTIC AND BLOCKING THE TIP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGE 1ML LS SP120 EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGES SHOW DEFECTS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2105074. MEDICAL DEVICE EXPIRATION DATE: 2026-04-30 . DEVICE MANUFACTURE DATE: 2021-04-28. MEDICAL DEVICE LOT #: 2102021. MEDICAL DEVICE EXPIRATION DATE: 2026-01-31. DEVICE MANUFACTURE DATE: 2021-02-01.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYRINGE 1ML LS SP120 EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGES SHOW DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523027 SYRINGE 1ML LS SP120 SYRINGE FMF BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown