BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL 1QT RED

    MDR report key: 11609789 · Received April 2, 2021

    Report

    Report Number
    2243072-2021-00933
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 9, 2021
    Report Date
    June 8, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903056354
    PMA / PMN Number
    K943139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTO OR SAMPLE REPRESENTATION WAS PROVIDED FOR THE COMPLAINT. ACCORDING TO THE DHR REVIEW PROCESS, THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE MISSING LIDS 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 LIDS FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. ACCORDING WITH THIS INVESTIGATION THERE IS NOT ENOUGH INFORMATION LIKE A PICTURE OR PACKAGING IDENTIFICATION PROVIDED FROM CUSTOMER, THE CURRENT PROCESS CONTROLS WERE REVIEWED, AND THE FOLLOWING WAS FOUND, THE PIECES ARE MANUALLY COUNTED AND VISUALLY VERIFIED WITH A SMART SCALE TO MAKE SURE THAT THE CORRECT QUANTITY OF PIECES ARE IN THE PACK, HOWEVER, THERE ARE MANY VARIABLES THAT COULD GENERATE THIS FAILURE MODE DUE TO INCORRECT HANDLING OR PARTIAL SELL¿S PERFORMED BY DISTRIBUTOR, THEREFORE, ADDITIONAL INFORMATION FROM PACKAGING IS NEEDED IN ORDER TO RULE OUT THAT THIS ISSUE WAS GENERATED BY DISTRIBUTOR, REPACKING PROCESS OR MANUFACTURING PROCESS. ROOT CAUSE REMAINS UNKNOWN BUT POSSIBLE ONES ARE NON-CONTROLLED METHOD (RE-PACKAGING) TO SHIP PARTIAL BOXES TO END USER OR PRODUCT DAMAGED DURING THE SHIPMENT, STORAGE OR DISTRIBUTION. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 18 SHARPS COLL 1QT RED EXPERIENCED A MISSING LID OR SLIDE LID/CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305635 BATCH NO: 0281918 ISSUE WITH LID ¿ NO LIDS (CUSTOMER SAID THEY ALREADY RECEIVED REPLACEMENT PRODUCT FROM THEIR DISTRIBUTOR, BUT HE STILL HAS 18 WITHOUT LIDS).

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: 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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. 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

    IT WAS REPORTED THAT 18 SHARPS COLL 1QT RED EXPERIENCED A MISSING LID OR SLIDE LID/CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305635, BATCH NO: 0281918. ISSUE WITH LID ¿ NO LIDS (CUSTOMER SAID THEY ALREADY RECEIVED REPLACEMENT PRODUCT FROM THEIR DISTRIBUTOR, BUT HE STILL HAS 18 WITHOUT LIDS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507126 SHARPS COLL 1QT RED HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305635 0281918 00382903056354

    Patients

    Seq Age Sex Outcome Treatment
    1