BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SHARPS COLLECTOR

    MDR report key: 8499234 · Received April 10, 2019

    Report

    Report Number
    2243072-2019-00696
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Date of Event
    March 26, 2019
    Report Date
    April 29, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903054874
    PMA / PMN Number
    K943139
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ACCORDING TO THE DHR REVIEW PROCESS; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE DEFORMING DITCHES DURING THE MANUFACTURING PROCESS OF THE LOT NUMBER REPORTED UNDER THIS CUSTOMER COMPLAINT. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE MISSING LOCKING TAB FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. BASED ON PICTURES PROVIDED FROM CUSTOMER IT CAN BE SEEN THE FOLLOWING: 1. IT CAN¿T BE SEEING DEFORMITIES, CRACK, FLASH, OR ANY MOLDING DEFECT THAT COULD AFFECTS THE FIT FORM OR FUNCTION OF THE LID. 2. IT CAN CONFIRM THAT THE COLLECTOR WAS NOT OVERFILLED. BASED ON INFORMATION PROVIDED IT WAS NOT POSSIBLE DETERMINE THE ROOT CAUSE LIKE A FAILURE MODE RELATED TO THE MANUFACTURING PROCESS SINCE THERE WERE NO ISSUES OBSERVED IN THE PICTURES PROVIDED (AS PART OF EVALUATION IT CAN¿T BE SEEN MOLDING ISSUES THAT COULD CAUSE THIS KIND OF FAILURES).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SHARPS COLLECTOR LID WAS DEFORMED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DITCHES ON THE LID WERE DEFORMED AND THE LID DIDN'T CLOSE COMPLETELY.

    Additional Manufacturer Narrative · 1

    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 BD¿ SHARPS COLLECTOR LID WAS DEFORMED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DITCHES ON THE LID WERE DEFORMED AND THE LID DIDN'T CLOSE COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292046 BD¿ SHARPS COLLECTOR HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 8243904 50382903054874

    Patients

    Seq Age Sex Outcome Treatment
    1 Other