BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET

    MDR report key: 8616518 · Received May 16, 2019

    Report

    Report Number
    2243072-2019-00937
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    May 1, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903056045
    PMA / PMN Number
    K943140
    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: NO SAMPLES OR PICTURES WERE RECEIVED. THREE ATTEMPTS TO GET MORE INFORMATION OR PICTURES WERE MADE, HOWEVER IN NONE OF THE CASES ADDITIONAL INFORMATION WERE PROVIDED. THE DHR REVIEW PROCESS WAS NOT ABLE TO BE PERFORMED DUE TO THE LOT NUMBER WAS UNKNOWN. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE LID CRACKED FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. ACCORDING WITH THIS INVESTIGATION THERE IS NO ENOUGH INFORMATION PROVIDED FROM CUSTOMER LIKE A PICTURE FROM THE ORIGINAL PACKAGING TO DETERMINE THE ROOT CAUSE OF THIS NON-CONFORMANCE. ADDITIONALLY, A REVIEW OF THE DHRS FOR THE LAST FIVE LOTS (9136972, 9138962, 9139917, 9140924, AND 9141961) MANUFACTURED FOR THE PART NUMBER 305604 WAS PERFORMED; THE RESULT DOESN¿T SHOWED ISSUES LIKE NCMR¿S DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET LID WAS FOUND CRACKED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "BEFORE USE, THE LID WAS CRACKED."

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FLEXTRONICS. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4), NJ HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET LID WAS FOUND CRACKED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(4) TO ENGLISH: "BEFORE USE, THE LID WAS CRACKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407826 BD¿ CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET SHARPS COLLECTOR FMI BECTON DICKINSON UNKNOWN 50382903056045

    Patients

    Seq Age Sex Outcome Treatment
    1 Other