BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK ¿ - 3-PIECE SYRINGE

    MDR report key: 16527236 · Received March 12, 2023

    Report

    Report Number
    1213809-2023-00190
    Event Type
    Malfunction
    Date Received
    March 12, 2023
    Date of Event
    February 10, 2023
    Report Date
    April 26, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903009121
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED.

    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. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK ¿ - 3-PIECE SYRINGE EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NOTIFIER DECLARES A DEFECT ON THE PRODUCT LER LOCK SYRINGE 3 PIECES 10ML STERILISEE RAYON GAMMA (PLASTIPAK), REF 300912, LOT ALL IN THE CHEMOTHERAPY PREPARATION UNIT, WE HAVE RECENTLY BEEN USING NEW 10ML LUER LOCK SYRINGES. AS SOON AS WE WITHDRAW COLOURED PRODUCTS (DOXORUBICIN, A RED COLOURED PRODUCT FOR EXAMPLE), THE BODY OF THE SYRINGE BECOMES COMPLETELY COLOURED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK ¿ - 3-PIECE SYRINGE EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NOTIFIER DECLARES A DEFECT ON THE PRODUCT LER LOCK SYRINGE 3 PIECES 10ML STERILISEE RAYON GAMMA (PLASTIPAK), REF (B)(4), LOT ALL. IN THE CHEMOTHERAPY PREPARATION UNIT, WE HAVE RECENTLY BEEN USING NEW 10ML LUER LOCK SYRINGES. AS SOON AS WE WITHDRAW COLOURED PRODUCTS (DOXORUBICIN, A RED COLOURED PRODUCT FOR EXAMPLE), THE BODY OF THE SYRINGE BECOMES COMPLETELY COLOURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677984 BD PLASTIPAK ¿ - 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 00382903009121

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown