BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL BNS

    MDR report key: 9285526 · Received November 6, 2019

    Report

    Report Number
    1213809-2019-01114
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 22, 2019
    Report Date
    December 27, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO OF A LOOSE 10ML SYRINGE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A SMALL BLACK FOREIGN MATTER PARTICLE ON THE PLUNGER ROD OUTSIDE THE FLUID PATH. THE COMPOSITION OF THE PARTICLE WAS UNCLEAR BASED ON THE PHOTO PROVIDED. THE PHOTO WAS ADJUSTED FOR SIZE AND THE PARTICLE APPEARED TO BE LARGER THAN LEVEL 3 IN SIZE AND WAS REJECTABLE PER PRODUCT SPECIFICATION. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. THE ROOT CAUSE WAS UNDETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML LL BNS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WOULD LIKE TO CONTACT YOU TODAY REGARDING A NON-CONFORMITY DETECTED ON YOUR PRODUCT: 301029 - SERING. 10ML 3P LLM BD. AS WE HAVE NOTICED THE PRESENCE OF AN EXOGENOUS ELEMENT ON THE PISTON OF THE SYRINGE. MORE PRECISELY, ON THE LOT (8026820).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (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 · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 10ML LL BNS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WOULD LIKE TO CONTACT YOU TODAY REGARDING A NON-CONFORMITY DETECTED ON YOUR PRODUCT: 301029 - SERING. 10ML 3P LLM BD. AS WE HAVE NOTICED THE PRESENCE OF AN EXOGENOUS ELEMENT ON THE PISTON OF THE SYRINGE. MORE PRECISELY, ON THE LOT (8026820).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077759 SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8026820

    Patients

    Seq Age Sex Outcome Treatment
    1 Other