BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SHARPS COLL 7.6L 24

    MDR report key: 13031892 · Received December 17, 2021

    Report

    Report Number
    2243072-2021-02938
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    November 19, 2021
    Report Date
    March 15, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    MMK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: THE 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. 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

    OEM MANUFACTURER: THE 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. 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

    H.6. INVESTIGATION: THE CUSTOMER COMPLAINED OF AN ISSUE SEALING SHARPS CONTAINER MATERIAL# 5460-ZKP. NO PHOTO OR SAMPLE WAS RECEIVED FOR TESTING AND THE COMPLAINT AND THE FAILURE CANNOT BE VERIFIED. THE ROOT CAUSE REMAINS UNKNOWN. THE INFORMATION RECEIVED WAS FORWARDED TO THE SUPPLIER FOR FURTHER INSPECTION. THE PRODUCTION RECORDS WERE REVIEWED AND NO ABNORMALITIES WERE PRESENTED DURING PRODUCTION AND NO FURTHER ISSUES HAVE BEEN RAISED WITH THIS PRODUCT/ LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SHARPS COLL 7.6L 24 THE LID WAS DIFFICULT TO CLOSE AND SEAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "COVER OF THE 7.6L SHARP BOX IS DIFFICULT TO SEAL."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SHARPS COLL 7.6L 24 THE LID WAS DIFFICULT TO CLOSE AND SEAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "COVER OF THE 7.6L SHARP BOX IS DIFFICULT TO SEAL."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SHARPS COLL 7.6L 24 THE LID WAS DIFFICULT TO CLOSE AND SEAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "COVER OF THE 7.6L SHARP BOX IS DIFFICULT TO SEAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928829 BD SHARPS COLL 7.6L 24 SHARPS CONTAINER MMK BECTON DICKINSON 1E804

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown