BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CENTRIC LUER-LOCK HYPODERMIC THREE-PIECE SYRINGE

    MDR report key: 14675189 · Received June 13, 2022

    Report

    Report Number
    1213809-2022-00333
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    March 8, 2022
    Report Date
    August 13, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL: YES D.10. RETURNED TO MANUFACTURER ON: 03-AUG-2022 H.6. INVESTIGATION SUMMARY: FIVE 3ML LUER-LOCK SYRINGES AND ONE PHOTO (P/N 309658) WERE RECEIVED AND EVALUATED. NO FOREIGN MATTER WAS OBSERVED IN ANY OF THE SYRINGES FROM THE SAMPLES RECEIVED. THE PHOTO SHOWS A 3ML SYRINGE WITH AN UNKNOWN RED TIP CAP ATTACHED AND TWO PIECES OF WHITE PARTICULATE INSIDE THE TIP THREAD AREA OF THE SYRINGE. A SAMPLE OF THE SYRINGE WITH THE FOREIGN MATTER IS REQUIRED TO PERFORM FOURIER TRANSFORM INFRARED SPECTROSCOPY ( FTIR) ANALYSIS TO DETERMINE FOREIGN MATTER COMPOSITION. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1181132. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (B)(6). INITIAL REPORTER FAX #: (B)(6). 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 · 0

    IT WAS REPORTED BEFORE USE THE BD PLASTIPAK¿ CENTRIC LUER-LOCK HYPODERMIC THREE-PIECE SYRINGE THERE IS AN ISSUE WITH FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PREPARING ASEPTIC PREPARATIONS IN BD PLASTIPAK LUERLOK 3ML AND 5ML SYRINGES, WE FIND WHITE PARTICLES IN THE SYRINGE THREAD. THIS HAS FREQUENTLY OCCURRED WITH VINCRISTINE FROM TEVA, BUT HAS ALSO BEEN NOTICED WITH AZACITDINE. THE SYRINGES ARE SEALED WITH KOMBIROT CAPS FROM BRAUN. THE SOLUTIONS ARE BOTH DILUTED AND UNDILUTED. IF REQUIRED, I HAVE PHOTOGRAPHIC MATERIAL AND RESERVE SAMPLES."

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THE BD PLASTIPAK¿ CENTRIC LUER-LOCK HYPODERMIC THREE-PIECE SYRINGE THERE IS AN ISSUE WITH FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PREPARING ASEPTIC PREPARATIONS IN BD PLASTIPAK LUERLOK 3ML AND 5ML SYRINGES, WE FIND WHITE PARTICLES IN THE SYRINGE THREAD. THIS HAS FREQUENTLY OCCURRED WITH VINCRISTINE FROM TEVA, BUT HAS ALSO BEEN NOTICED WITH AZACITDINE. THE SYRINGES ARE SEALED WITH KOMBIROT CAPS FROM BRAUN. THE SOLUTIONS ARE BOTH DILUTED AND UNDILUTED. IF REQUIRED, I HAVE PHOTOGRAPHIC MATERIAL AND RESERVE SAMPLES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366565 BD PLASTIPAK¿ CENTRIC LUER-LOCK HYPODERMIC THREE-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309658 1181132 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown