BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL WALLMATE 5.4QT BEIGE

    MDR report key: 9591215 · Received January 15, 2020

    Report

    Report Number
    2243072-2020-00038
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    December 30, 2019
    Report Date
    February 19, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903055505
    PMA / PMN Number
    K943141
    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 A SAMPLE AND PHOTO REPRESENTATION WAS PROVIDED, AND ADDITIONAL EVIDENCE OF ORIGINAL PACKAGING WAS AVAILABLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND NON-CONFORMING MATERIAL REPORT (NCMR) FOR THE REPORTED LOT WAS PERFORMED FOR THE PAST 12 MONTHS. THERE WERE NO MANUFACTURING OR MATERIAL DEFECTS REPORTED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AN INVESTIGATION WAS PERFORMED TO REVIEW THE CURRENT MANUFACTURING PROCESSES. ALL MATERIAL IS 100% INSPECTED BY THE PRODUCTION DEPARTMENT. ALSO, A SECOND INSPECTION IS PERFORMED BASED ON AN AQL SAMPLING PLAN BY A QUALITY AUDITOR. IT IS LIKELY THAT THE DAMAGE OCCURRED AFTER DISTRIBUTION AND WAS DAMAGED IN TRANSIT DURING SHIPPING OR HANDLING. BD WILL CONTINUE TO MONITOR THE COMPLAINT FOR ANY TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHARPS COLL WALLMATE 5.4QT BEIGE WAS BROKEN. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305550 BATCH NO: 9210930 IT WAS REPORTED THAT THE PRODUCT WAS BROKEN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 SHARPS COLL WALLMATE 5.4QT BEIGE WAS BROKEN. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305550 BATCH NO: 9210930. IT WAS REPORTED THAT THE PRODUCT WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57482 SHARPS COLL WALLMATE 5.4QT BEIGE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305550 9210930 50382903055505

    Patients

    Seq Age Sex Outcome Treatment
    1 Other