BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL EURO 125 S/C

    MDR report key: 11936652 · Received June 3, 2021

    Report

    Report Number
    1213809-2021-00396
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    April 29, 2021
    Report Date
    September 3, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096497
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SAMPLE WAS RECEIVED AND ONE PHOTO WAS FORWARDED TO THE MANUFACTURING SITE AND EVALUATED. THE PHOTO SHOWED A LOOSE EMPTY 5ML SYRINGE WITH ITS PLUNGER EXTENDED TO THE NOMINAL CAPACITY LINE. A LENGTHWISE CRACK WAS OBSERVED TO BE PRESENT IN THE BARREL BETWEEN APPROXIMATELY 1ML AND 4.5ML GRADE LINES OUTSIDE THE SCALE MARKINGS. POTENTIAL ROOT CAUSE FOR THE BARREL CRACKED DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH 0213256 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 5ML LL EURO 125 S/C WAS DAMAGED. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE WITHDRAWAL OF PPI WATER FOR RECONSTITUTION OF A VIDAZA VIAL, A CRACK IN THE BODY OF A SYRINGE WAS DETECTED. NO CLINICAL CONSEQUENCE FOR THE OPERATOR OR THE PATIENT. CONSEQUENCES: RETENTION OF THE DEFECTIVE SYRINGE AND QUARANTINE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 5ML LL EURO 125 S/C WAS DAMAGED. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE WITHDRAWAL OF PPI WATER FOR RECONSTITUTION OF A VIDAZA VIAL, A CRACK IN THE BODY OF A SYRINGE WAS DETECTED. NO CLINICAL CONSEQUENCE FOR THE OPERATOR OR THE PATIENT. CONSEQUENCES: RETENTION OF THE DEFECTIVE SYRINGE AND QUARANTINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833049 SYRINGE 5ML LL EURO 125 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0213256 00382903096497

    Patients

    Seq Age Sex Outcome Treatment
    1