BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL EURO 125 S/C

    MDR report key: 12345283 · Received August 19, 2021

    Report

    Report Number
    1213809-2021-00583
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    July 19, 2021
    Report Date
    September 6, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUATION? YES. D10: RETURNED TO MANUFACTURER ON: 2021-08-17 H6: INVESTIGATION SUMMARY FOUR 5ML SYRINGES SEALED IN BLISTERPAKS FROM BATCH #9200381 WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. ONE SYRINGE'S PACKAGING APPEARED TO HAVE BEEN HANDLED ROUGHLY WITH CRINKLING EVIDENT, HOWEVER A PROPER SEAL WAS STILL MAINTAINED. THE OTHER THREE SYRINGE PACKAGES RECEIVED WERE NOT OBSERVED TO HAVE ANY VISUAL DEFECTS PRESENT. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. THE SYRINGE 5ML LL 125 CT WITHOUT NEEDLE EUROGRAPHICS IS STERILIZED VIA E-BEAM IRRADIATION AT BD CANAAN PER ISO 11137 REQUIREMENTS AND BD INTERNAL PROCEDURES. MATERIAL # 309649 - BATCH #9200381 WAS PROCESSED ACCORDING TO BD REQUIREMENTS FOR STERILE DEVICES PER PRODUCT SPECIFICATIONS. THE STERILIZATION DOSE ESTABLISHMENT IS BASED ON ISO 11137 GUIDANCE FOR A STERILITY ASSURANCE LEVEL (SAL) OF 10^-6. THIS IS SUPPORTED BY QUARTERLY STERILIZATION DOSE AUDITS (SDA) TO ENSURE THE PROPER DOSE IS BEING APPLIED TO MEET THE CLAIMED STERILITY ASSURANCE LEVEL (SAL). IN GENERAL, BIOBURDEN OR MICROBIAL LIMIT TESTING IS PERFORMED ON NON-STERILIZED PRODUCT. TESTING OF A STERILE PRODUCT SHOULD BE PERFORMED BY A COMPENDIAL STERILITY TEST AS DESCRIBED IN USP/EP/JP OR OTHER RELEVANT GUIDANCE. BD CANAAN DOES NOT RECOGNIZE A BIOBURDEN OR MICROBIAL LIMITS TEST ON STERILIZED PRODUCT AS THIS IS NOT THE APPROPRIATE TEST FOR DETERMINING PRODUCT STERILITY. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED SYRINGE 5ML LL EURO 125 S/C HAD STERILITY ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRODUCT FAILED STERILITY TEST IN THIRD PARTY SITE".

    Additional Manufacturer Narrative · 1

    (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 SYRINGE 5ML LL EURO 125 S/C HAD STERILITY ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRODUCT FAILED STERILITY TEST IN THIRD PARTY SITE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238331 SYRINGE 5ML LL EURO 125 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309649 9200381 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1