BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NESTABLE SHARPS COLLECTOR

    MDR report key: 13758222 · Received March 14, 2022

    Report

    Report Number
    2243072-2022-00338
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    February 21, 2022
    Report Date
    May 10, 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

    OEM MANUFACTURER: 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 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 THE DHR REVIEW PROCESS WAS PERFORMED AND 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. 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. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD¿ NESTABLE SHARPS COLLECTORS' LIDS COULD NOT BE ATTACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THIS IS A REPORT ABOUT A LID ISSUE OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, THE LID COULD NOT BE ATTACHED TO THE BASE IN THREE PRODUCTS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD¿ NESTABLE SHARPS COLLECTORS' LIDS COULD NOT BE ATTACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT A LID ISSUE OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, THE LID COULD NOT BE ATTACHED TO THE BASE IN THREE PRODUCTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293776 BD¿ NESTABLE SHARPS COLLECTOR HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305487 1221904 00382903054879

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown