BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 60ML S/T LATEX FREE CONFIGURE

    MDR report key: 9312218 · Received November 12, 2019

    Report

    Report Number
    1911916-2019-01197
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 25, 2019
    Report Date
    November 26, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096542
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE RECEIVED; THEREFORE, SAMPLE ANALYSIS COULD NOT BE PERFORMED AND THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. THEREFORE, A POTENTIAL ROOT CAUSE(S) CANNOT BE DETERMINED. BD PERFORMS BIOBURDEN TESTING ONCE EVERY THREE (3) MONTHS FOR EACH PRODUCT FAMILY. THIS TESTING INCLUDES TESTING FOR MOLD. MONTHLY ENVIRONMENTAL TESTING IS ALSO PERFORMED IN THE PRODUCTION AREA. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    MATERIAL NO.: 309654, BATCH NO.: 9133518. IT WAS REPORTED THAT BEFORE USE OF THE BD SYRINGE 60ML S/T LATEX FREE CONFIGURE THERE IS A MOLD-LIKE SUBSTANCE FOUND ON ITEM INSIDE OF PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSSIBLE MOLD ON ITEM PACKAGE IS WRAPPED.

    Additional Manufacturer Narrative · 1

    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

    MATERIAL NO.: 309654 BATCH NO.: 9133518. IT WAS REPORTED THAT BEFORE USE OF THE BD SYRINGE 60ML S/T LATEX FREE CONFIGURE THERE IS A MOLD-LIKE SUBSTANCE FOUND ON ITEM INSIDE OF PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSSIBLE MOLD ON ITEM PACKAGE IS WRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103453 BD SYRINGE 60ML S/T LATEX FREE CONFIGURE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 9133518 30382903096542

    Patients

    Seq Age Sex Outcome Treatment
    1 Other