BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SHARPS COLL CHEMO 3GAL YELLOW NEW CAP

    MDR report key: 15749220 · Received November 7, 2022

    Report

    Report Number
    2243072-2022-01899
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Date of Event
    September 22, 2022
    Report Date
    December 2, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903050765
    PMA / PMN Number
    K943140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 03-NOV-2022. H.6. INVESTIGATION SUMMARY: 18 SAMPLES WERE RETURNED BY THE CUSTOMER. IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT IS SUPPOSED TO BE 305076 BUT THEY ARE LABELED 305489 COULD BE VERIFIED AND OBSERVED THAT 18 PARTS OF THE 305076, 3 GALLON SHARPS CONTAINERS HAD THE WRONG PRODUCT LABEL ON THEM (305489). ALL TESTING WAS WITHIN SPECIFICATION. REQUIREMENT(S): THE CORRECT PRODUCT LABELS SHOULD BE ON THE BOTTLES WITH THE CORRECT PRODUCT #. INVESTIGATION: (DESCRIBE THE ROOT CAUSE) AN ISSUE WAS DETECTED IN JULY 2022 WHERE THE WRONG PRODUCT LABELS HAD BEEN APPLIED TO THE PRODUCT. THIS WAS DUE TO THE PRODUCT LABELS BEING STORED IN CLOSE PROXIMITY TO EACH OTHER IN THE QUALITY LAB STORAGE AREA. AFTER THE ISSUE WAS RECTIFIED, THE LABELS WERE SEPARATED BY PRESS IN THE AREA WHERE THEY ARE STORED. THE PROBLEM WAS THOUGHT TO HAVE BEEN FULLY CONTAINED. THIS IS A BOUNDING/CONTAINMENT ISSUE. CORRECTIVE ACTION: SEPARATION OF LABELS IN THE STORAGE AREA WITH PROPER SIGNS FOR WHICH PRESS THEY GO TO. PREVENTIVE ACTION: LABEL VERIFICATION ENSURES THAT WHEN LABEL ROLLS CHANGE, THE QUALITY INSPECTOR ON SHIFT CONFIRMS THE LABEL INFORMATION IS THE SAME AND ACCURATE. CONCLUSION : THIS ISSUE WAS A PREVIOUSLY DETECTED ISSUE WHICH WAS SIMPLY NOT BOUNDED WELL ENOUGH. CA/PA HAVE ALREADY BEEN IMPLEMENTED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT 18 BD SHARPS COLL CHEMO 3GAL YELLOW NEW CAP HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE SUPPOSED TO BE VENDOR NUMBER: 305076 3 GALLON YELLOW, BUT THEY HAVE VENDOR NUMBER: 305489 6.9 QT RED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT 18 BD SHARPS COLL CHEMO 3GAL YELLOW NEW CAP HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE SUPPOSED TO BE VENDOR NUMBER 305076 3 GALLON YELLOW, BUT THEY HAVE VENDOR NUMBER 305489 6.9 QT RED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334621 BD SHARPS COLL CHEMO 3GAL YELLOW NEW CAP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 2188001 00382903050765

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown