BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT

    MDR report key: 13891758 · Received March 24, 2022

    Report

    Report Number
    2243072-2022-00389
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    March 7, 2022
    Report Date
    May 16, 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 FLEXTRONICS. 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 IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: 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 6 NCS WERE GENERATED FOR THE SAME DEFECT IN THE LAST 5 YEARS, THE VERY LAST EVENT WAS REPORTED BACK IN THE LAST 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. BASED ON THE INVESTIGATION AND EVIDENCE PROVIDED, THIS ISSUE IS CONFIRMED AS MANUFACTURING PROCESS RELATED DUE TO THE ISSUE WAS GENERATED BY A MOLD BROKEN INSERT AND LINE CLEARANCE WAS NOT PROPERLY FOLLOWED AT THE TIME TO DETECT THE BROKEN INSERT. THE INVESTIGATION SHOWED TWO ROOT CAUSES REGARDING THIS ISSUE: ¿ ONE: MOLD HAS EXCEEDED THE LIFE CYCLE AND THERE IS AN IMPROVEMENT OPPORTUNITY ON THE MOLD INSERT DESIGN. ¿ SECOND: THE SEGREGATION PROCESS WAS NOT PROPERLY FOLLOWED CAUSING AN ESCAPE ON THE PRODUCT SHIPPED TO CUSTOMER. AS PART OF THE INVESTIGATION RESULTS IT WAS CONFIRMED THAT DAMAGED MOLD INSERT WAS REPLACED SUCCESSFULLY BY TOOL ROOM DEPARTMENT, QUALITY ALERT WAS POSTED TO MAKE AWARE ALL PEOPLE INVOLVED ON THIS ISSUE AND A RE-TRAINING WAS MADE ON THE SEGREGATION PROCESS. ALSO, THE CURRENT MANUFACTURING PROCESS HAS BEEN EVALUATED AND CONFIRMED THAT THERE ARE CONTROLS TO DETECT THIS KIND OF DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT THE LID DID NOT FIT THE COLLECTOR AS THE ASSEMBLY WAS DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE LID COULD NOT BE ASSEMBLED ONTO THE BASE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT THE LID DID NOT FIT THE COLLECTOR AS THE ASSEMBLY WAS DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE LID COULD NOT BE ASSEMBLED ONTO THE BASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320413 BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1.5 QT NEEDLE PORT HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305487 1215902 00382903054879

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown