BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT

    MDR report key: 14242448 · Received April 28, 2022

    Report

    Report Number
    2243072-2022-00594
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 7, 2022
    Report Date
    June 7, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903054879
    PMA / PMN Number
    K943139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 05-MAY-2022. H.6. INVESTIGATION: PICTURES FROM SAMPLES WERE SENT TO VH SHOWING THE DEFECT ON THE LIDS. ACCORDING TO THE DHR REVIEW PROCESS; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE LOCKS DEFECTIVE DURING THE MANUFACTURING PROCESS OF THE LOT NUMBER REPORTED UNDER THIS CUSTOMER COMPLAINT. A REVIEW OF THE HISTORICAL NCMR¿S FOR THE AFFECTED COMPONENT (LID) UNDER PART NUMBER BDX-8990020 WAS MADE AND IT WAS FOUND THAT 7 NCS WERE GENERATED FOR THE SAME DEFECT IN THE LAST 5 YEARS, THE VERY LAST EVENT WAS REPORTED IN APRIL OF THE CURRENT YEAR. ACCORDING TO THE PHOTOS RECEIVED FROM CUSTOMER, IT CAN BE SEEN THE FOLLOWING: ¿ THERE IS AN OBSTRUCTION BY EXCESS OF PLASTIC MATERIAL ON LID¿S SKIRT, WHICH SEEMS TO BE GENERATED BY A BROKEN INSERT IN THE MOLD. THEREFORE, THE LID CAN¿T FIT THE BASE WHEN TRYING TO ASSEMBLY BY END USER. FOR FURTHER DETAILS SEE SECTION ¿INVESTIGATION DETAILS¿. ACCORDING WITH THIS EVIDENCE, WE CAN DETERMINE THIS ISSUE AS A MANUFACTURING RELATED TOPIC SINCE THIS KIND OF ISSUES ARE GENERATED DUE TO A DAMAGED ON THE MOLD (BROKEN INSERT) DURING THE INJECTION MOLDING PROCESS. AS PART OF THIS INVESTIGATION, A REVIEW OF CUSTOMER COMPLAINT RECORDS WAS CONDUCTED AND ACCORDING TO PREVIOUS CC RECORD, AT THE TIME WHERE THIS INVESTIGATION TOOK PLACE IT WAS REPORTED MORE EVENTS IN WHERE THE SAME PIECE OF PLASTIC WAS STICK TO THE LID. BASED ON ABOVE EVIDENCE, THE ROOT CAUSE WHY THE EVENT HAPPENED AND THE MOTIVE WHY THE PARTS WERE SENT OUT ARE: ¿ MOLD INSERTS BROKEN SINCE MOLD ACHIEVED THE END OF LIFE (DOUBLED THE DESIGN QUANTITY REQUIREMENTS) AND LIFE CYCLE HAS BEEN EXCEEDED; IN OTHER WORDS, THE TOOL WORN OUT/DESIGN LEADED TO THE STEEL FAILURE. ¿ THE FAILURE INDICATES THAT MOLD DESIGN IS ANOTHER FACTOR THAT CONTRIBUTE TO THE DAMAGES ON THE MOLD INSERTS BECAUSE THE DESIGN OF THOSE INSERTS HAS TWO ASYMMETRIC TABS AND THE DAMAGE ALWAYS OCCUR ON THE THINNER TAB. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT THE LID COULD NOT BE CLOSED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT SHARPS COLLECTOR'S LID THAT DOESN'T SHUT. ACCORDING TO THE CUSTOMER'S REPORT, THE LID DOESN'T SHUT; SOMETHING MAY BE STUCK INTO THE LID.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT THE LID COULD NOT BE CLOSED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT SHARPS COLLECTOR'S LID THAT DOESN'T SHUT. ACCORDING TO THE CUSTOMER'S REPORT, THE LID DOESN'T SHUT; SOMETHING MAY BE STUCK INTO THE LID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109903 BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305487 1175904 00382903054879

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown