BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL 8QT NEST OPEN TOP NEEDL PORT

    MDR report key: 10687901 · Received October 15, 2020

    Report

    Report Number
    2243072-2020-01657
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 23, 2020
    Report Date
    November 9, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903053433
    PMA / PMN Number
    K943134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR# 2243072-2020-01657 HAS BEEN DETERMINED TO BE NOT REPORTABLE. THE PRODUCT WAS REPORTED TO BE MISSING THE ABSORBENT PAD. THIS PRODUCT DOES NOT COME WITH AN ABSORBENT PAD. GENERAL DISSATISFACTION OF THE PRODUCT DOES NOT IMPACT THE INTENDED USE OF THE DEVICE WHICH WOULD NOT LEAD TO SERIOUS INJURY OR HARM TO THE CLINICIAN OR PATIENT. MFR# 2243072-2020-01657 IS VOID.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ABSORBING PADS WERE MISSING IN THE SHARPS COLL 8QT NEST OPEN TOP NEEDL PORT IN LOTS 0026928 AND 9307913 BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ABSORBENT PAD MISSING IN THE SHARP 305343".

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: (B)(4). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0026928, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2020-02-08, MEDICAL DEVICE LOT #: 9307913, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2019-11-13. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABSORBING PADS WERE MISSING IN THE SHARPS COLL 8QT NEST OPEN TOP NEEDL PORT IN LOTS 0026928 AND 9307913 BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ABSORBENT PAD MISSING IN THE SHARP 305343".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152604 SHARPS COLL 8QT NEST OPEN TOP NEEDL PORT HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305343 SEE SECTION H.10. 50382903053433

    Patients

    Seq Age Sex Outcome Treatment
    1 Other