BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL 9GAL GASKET RED

    MDR report key: 8906265 · Received August 19, 2019

    Report

    Report Number
    2243072-2019-01752
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    July 26, 2019
    Report Date
    September 12, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903056014
    PMA / PMN Number
    K943575
    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: IT WAS REPORTED THAT LIDS WERE MISSING. A SAMPLE AND PHOTO REPRESENTATION WAS PROVIDED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT WAS PERFORMED AND THERE WERE NO ISSUES FOUND FOR MISSING LIDS. A REVIEW OF NON-CONFORMING MATERIAL REPORT (NCMR) WAS PERFORMED FOR THE LAST TWELVE MONTHS AND DID NOT IDENTIFY ANY NONCONFORMANCE REPORTED FOR MISSING LIDS FOR THE SAME PART NUMBER. THIS LOT WAS CONFIRMED PRODUCED AFTER CORRECTIVE ACTIONS. A WEIGHT SYSTEM THAT PROVIDES A WEIGHTED LABEL FOR EACH FINAL BOX BEFORE SHIPMENT HAS ALREADY BEEN IMPLEMENTED FOR THIS PRODUCT TO ENSURE THE CORRECT QUANTITY OF PIECES PER BOX BEFORE SHIPPING. IT WAS NOT POSSIBLE TO CONFIRM THAT ANY FAILURE MODE WAS RELATED TO THE MANUFACTURING PROCESS WITH THE INFORMATION PROVIDED SINCE THE WEIGHT SYSTEM IS VALIDATED AND DID NOT DETECT ANY MISSING COMPONENTS. THERE MAY HAVE POTENTIALLY BEEN A REPACKAGING ISSUE WHICH OCCURRED DURING DISTRIBUTION. THE ACTUAL ROOT CAUSE IS UNKNOWN. BASED ON THESE FINDINGS, OUR INVESTIGATION IS INCONCLUSIVE. BD WILL CONTINUE TO MONITOR FOR ANY TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHARPS COLL 9GAL GASKET RED EXPERIENCED A MISSING LID OR SLIDE CLAMP WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305601; BATCH NO. 9033926. IT WAS REPORTED THE LID WAS MISSING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FLEXTRONICS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHARPS COLL 9GAL GASKET RED EXPERIENCED A MISSING LID OR SLIDE CLAMP WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305601, BATCH NO. 9033926. IT WAS REPORTED THE LID WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698557 SHARPS COLL 9GAL GASKET RED HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 9033926 50382903056014

    Patients

    Seq Age Sex Outcome Treatment
    1 Other