BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 14492625 · Received May 24, 2022

    Report

    Report Number
    3002682307-2022-00145
    Event Type
    Malfunction
    Date Received
    May 24, 2022
    Date of Event
    April 28, 2022
    Report Date
    June 7, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903006137
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION HAVE BEEN PROVIDED FOR EVALUATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2202042, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2202042 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCTS WERE VISUALLY INSPECTED, NO LUBRICANT OR OTHER LIQUID WAS OBSERVED INSIDE ANY OF THE SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LIQUID WAS FOUND IN THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ONE NURSE HAD THE IMPRESSION OF SEEING A SCRATCH IN THE BODY OF THE SYRINGE AND ON CLOSER EXAMINATION THE PRESENCE OF A LIQUID IN THE SYRINGE; LIQUID THAT CAME OUT OF THE SYRINGE AFTER PUSHING ON THE PLUNGER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LIQUID WAS FOUND IN THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ONE NURSE HAD THE IMPRESSION OF SEEING A SCRATCH IN THE BODY OF THE SYRINGE AND ON CLOSER EXAMINATION THE PRESENCE OF A LIQUID IN THE SYRINGE; LIQUID THAT CAME OUT OF THE SYRINGE AFTER PUSHING ON THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878149 BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2202042 00382903006137

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown