BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE

    MDR report key: 16475958 · Received March 3, 2023

    Report

    Report Number
    1213809-2023-00141
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    January 16, 2023
    Report Date
    March 13, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096589
    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: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 27-FEB-2023. INVESTIGATION SUMMARY: SEVENTY-FOUR SAMPLES AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED ON RECEIVED SAMPLES. UPON EXAMINATION OF THE RETURNED PHOTOS, A VERTICAL CRACK/ SCRATCH WAS OBSERVED ALONG THE BARREL SURFACE OUTSIDE THE PRINT AREA EXTENDING FROM THE 1ML GRAD LINE TO 2ML GRAD LINE. POTENTIAL ROOT CAUSE FOR THE BARREL CRACK DEFECTS IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2221955. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BARREL OF THE BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE WAS CRACKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "THERE WAS A TEAR IN THE SYRINGE DURING DOSING ON THE SUBJECT. OWEVER, THIS TIME NO LIQUID LEAKED OUT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BARREL OF THE BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE WAS CRACKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "THERE WAS A TEAR IN THE SYRINGE DURING DOSING ON THE SUBJECT... HOWEVER, THIS TIME NO LIQUID LEAKED OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870514 BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2221955 00382903096589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown