BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SHARPS COLLECTOR

    MDR report key: 12920455 · Received December 2, 2021

    Report

    Report Number
    2243072-2021-02847
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 3, 2021
    Report Date
    January 24, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903056163
    PMA / PMN Number
    K943134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: 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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHOTO OR SAMPLE WAS RECEIVED WITH THE CUSTOMER'S COMPLAINT OF MISSING LIDS. WITHOUT FURTHER INFORMATION LIKE A PHYSICAL SAMPLE, THE COMPLAINT CANNOT BE VERIFIED AND THE ROOT CAUSE REMAINS UNKNOWN. A DHR REVIEW PROCESS WAS PERFORMED AND NO ISSUES LIKE MISSING LIDS WERE REPORTED. ALSO, A REVIEW OF NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE MISSING LIDS FOR THE SAME LOT NUMBER (1161913) THROUGHOUT THE LAST TWELVE MONTHS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: 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 · 0

    IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR WAS MISSING ITS LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER RECEIVED DELIVERY OF THIS ITEM AND THERE WERE NO LIDS WITH THE CONTAINERS- THE CASE WAS UNOPENED AND NOT DAMAGED WHEN IT DELIVERED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR WAS MISSING ITS LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER RECEIVED DELIVERY OF THIS ITEM AND THERE WERE NO LIDS WITH THE CONTAINERS- THE CASE WAS UNOPENED AND NOT DAMAGED WHEN IT DELIVERED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR WAS MISSING ITS LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER RECEIVED DELIVERY OF THIS ITEM AND THERE WERE NO LIDS WITH THE CONTAINERS- THE CASE WAS UNOPENED AND NOT DAMAGED WHEN IT DELIVERED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819230 BD¿ SHARPS COLLECTOR HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305616 1161913 00382903056163

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown