BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS DISPOSAL

    MDR report key: 9458233 · Received December 12, 2019

    Report

    Report Number
    2243072-2019-02797
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Date of Event
    November 25, 2019
    Report Date
    February 5, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K943683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF (B)(6) 2019 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. ACCORDING WITH THE DHR REVIEW INFORMATION, THE PROBLEM ¿NOT CLIPPING¿ HAS NO NHB ASSEMBLY PROCESS RELATION, ALL SAMPLES OF SAFE CLIP DISPOSABLE CUTTER (USA) PASSED FUNCTIONAL TEST (AQL C=0 AND AQL=1) AND VISUAL TEST (SAMPLE PLAN C=0 AND AQL= 1). AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) BD SAFE CLIP WITH THE SHELF CARTON FROM LOT # 7176531. CUSTOMER STATES THAT THE SAFE CLIP IS NO LONGER CLIPPING. THE RETURNED SAFE CLIP WAS EXAMINED UNDER THE MICROSCOPE AND EXHIBITED THE CUTTING HOLE BLOCKED WITH NEEDLES, WHICH CAN OCCUR DURING NORMAL USE OF THE PRODUCT. ACCORDING WITH THE DHR REVIEW INFORMATION ATTACHED, THE PROBLEM ¿NOT CLIPPING¿ HAS NO NHB ASSEMBLY PROCESS RELATION, ALL SAMPLES OF SAFE CLIP DISPOSABLE CUTTER (USA) PASSED FUNCTIONAL TEST (AQL C=0 AND AQL=1) AND VISUAL TEST (SAMPLE PLAN C=0 AND AQL= 1). THIS ISSUE IS NOT A MANUFACTURING DEFECT AS THE CUTTING HOLE BECOMING BLOCKED WITH NEEDLES CAN OCCUR DURING NORMAL USE OF THE PRODUCT BY THE CUSTOMER. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLIPPING ISSUE OCCURRED WITH A SHARPS DISPOSAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WILL NO LONGER CLIP NEEDLES. CLIPPED 300 NEEDLES SO FAR. WILL NO LONGER ACCEPT NEEDLE IN THE HOLE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLIPPING ISSUE OCCURRED WITH A SHARPS DISPOSAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WILL NO LONGER CLIP NEEDLES. CLIPPED 300 NEEDLES SO FAR. WILL NO LONGER ACCEPT NEEDLE IN THE HOLE."

    Additional Manufacturer Narrative · 1

    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. DEVICE EXPIRATION DATE: N/A. 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 A CLIPPING ISSUE OCCURRED WITH A SHARPS DISPOSAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WILL NO LONGER CLIP NEEDLES. CLIPPED 300 NEEDLES SO FAR. WILL NO LONGER ACCEPT NEEDLE IN THE HOLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257904 SHARPS DISPOSAL HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 7176531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other