BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ SHARPS COLLECTOR 3.1 FUNNEL CAP

    MDR report key: 6808343 · Received August 21, 2017

    Report

    Report Number
    2243072-2017-00100
    Event Type
    Injury
    Date Received
    August 21, 2017
    Date of Event
    August 1, 2017
    Report Date
    December 19, 2017
    Manufacturer
    BECTON DICKINSON
    Product Code
    MMK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: BD WAS ABLE TO CONFIRM THE REPORTED ISSUE. IN ORDER TO PREVENT THIS ISSUE FROM REOCCURRING ALL OPERATORS WERE/WILL BE RETRAINED TO INSPECT EACH LID PRIOR TO ASSEMBLY AND ON FULLY/ACCEPTABLE INSTALLED CAP INSTALLATION TOO BASE AND TO INSPECT CAP TO BASE ASSEMBLE BEFORE PLACING COMPLETED COLLECTOR IN BOX. QUALITY ALERT HAS BEEN PLACED AT MACHINE OF BOTH ISSUES. QUALITY AUDITS DURING RUN WILL BE INCREASED TO INSURE THAT TRAINING WAS EFFECTIVE. NON-CONFORMITY: LID CAME OFF OF COLLECTOR DURING USE AND SOME OF ITS CONTENTS FELL OUT AND POSSIBLY CAUSED A NSI ALSO LID WILL NOT SHUT. REQUIREMENT(S): LIDS MUST BE FULLY ATTACHED AND STAY ATTACHED TO BASE DURING USE, ALSO ALL LIDS MUST STAY SHUT WHEN IN TEMPORARY CLOSED POSITION. IMMEDIATE ACTION TAKEN: REVIEWED COMPLIANT WITH OPERATORS, PLACED IN HOUSE STOCK ON HOLD FOR INSPECTING. STARTED AN INVESTIGATION AND REVIEWED IN-PROCESS INSPECTION REPORTS. REWORK INSTRUCTIONS: OPEN EACH BOX REMOVE ALL 24 COLLECTORS AND PLACE ON WORK TABLE THEN ONE AT A TIME INSPECT LID TO BASE TO INSURE FULLY ATTACHMENT IS PRESENT THEN INSPECT TEMPORARY LID CLOSED TO INSURE THAT LID STAYS IN TEMPORARY CLOSED POSITION. IF NO ISSUES ARE FOUND PLACE COLLECTOR BACK IN BOX. IF ANY COLLECT IS FOUND TO HAVE ANY ISSUES NOTIFY QC MANAGER IMMEDIATELY FOR INVESTIGATION. IF AFTER INSPECTING ALL 24 PCS AND NO ISSUES ARE FOUND SEAL BOX AND REPEAT ON NEXT BOX. ALL SAMPLES WERE FOUND TO BE ACCEPTABLE. INVESTIGATION: (DESCRIBE THE ROOT CAUSE) IT IS BELIEVED THAT LID TO COLLECTOR SEPARATION WAS CAUSED BY OPERATOR FAILURE TO COMPLETELY SNAP LID TO BASE IN TURN CAUSING THE SEPARATION. A DETERMINATION FOR TEMPORARY CLOSED POSITION FAILURE OF LID CANNOT BE CONCLUDED AT THIS TIME WITHOUT EXAMINING THE LID FOR POSSIBLE DEFORMATION OF LID. DHR: NO NCR'S WERE RAISED DURING THE PRODUCTION OF THIS LOT. ALL TESTING WAS WITHIN SPECIFICATION. ALL OPERATORS WERE/WILL BE RETRAINED TO INSPECT EACH LID PRIOR TO ASSEMBLY AND ON FULLY/ACCEPTABLE INSTALLED CAP INSTALLATION TOO BASE AND TO INSPECT CAP TO BASE ASSEMBLE BEFORE PLACING COMPLETED COLLECTOR IN BOX. QUALITY ALERT HAS BEEN PLACED AT MACHINE OF BOTH ISSUES. QUALITY AUDITS DURING RUN WILL BE INCREASED TO INSURE THAT TRAINING WAS EFFECTIVE.

    Additional Manufacturer Narrative · 1

    CAT# WAS CORRECTED TO BE 300466, LOT# 6284001.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. 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 A BD¿ SHARPS COLLECTOR 3.1 FUNNEL CAP LID ¿FELL OFF¿ AND THE CONTENTS INSIDE ¿MIGHT¿ HAVE STUCK SOMEONE. THAT PERSON WAS SEEN BY HER DOCTOR FOR ASSESSMENT AND LAB WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587933 BD¿ SHARPS COLLECTOR 3.1 FUNNEL CAP SHARPS CONTAINER MMK BECTON DICKINSON 6284001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention