BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS COLL 1QT RED

    MDR report key: 11346572 · Received February 18, 2021

    Report

    Report Number
    2243072-2021-00362
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 12, 2021
    Report Date
    March 3, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903056354
    PMA / PMN Number
    K943139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ACCORDING TO THE DHR REVIEW PROCESS, THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE BASE CORNER BROKEN/DAMAGED DURING THE MANUFACTURING PROCESS OF THE LOT NUMBER REPORTED UNDER THIS CUSTOMER COMPLAINT. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE BASE CORNER BROKEN/DAMAGED FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. ACCORDING WITH PICTURES PROVIDED FROM CUSTOMER IT CAN BE SEEN THE FOLLOWING: 1. THE CORNER OF THE COLLECTOR WAS BROKEN. 2. THE LOT 0171909 WAS CONFIRMED LIKE THE LOT AFFECTED. 3. NO ADDITIONAL DAMAGES WERE OBSERVED ON THE COLLECTOR BASE. AS PART OF THIS INVESTIGATION IT WAS NOTICED THAT THIS ISSUE AROSE FROM A PRODUCT SOLD IN JAPAN THAT¿S WHY THE EVIDENCE OF THE PACKAGING USED WILL BE NEEDED TO DETERMINE THE ROOT CAUSE, BECAUSE IN ACCORDANCE TO PREVIOUS INFORMATION PROVIDED BY CUSTOMER ALL PRODUCT SOLD TO JAPAN IS BEING REPACKAGED. THEREFORE, DUE TO LACK OF EVIDENCE IT CAN¿T BE CONFIRMED THIS NONCONFORMANCE AS A FAILURE MODE RELATED TO A MANUFACTURING PROCESS, BECAUSE THIS KIND OF DAMAGES COULD BE GENERATED DUE TO DIFFERENT VARIABLES LIKE TRANSIT DAMAGED, INADEQUATE PACKAGING TO SEND THE PRODUCT TO THE END USER. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SHARPS COLL 1QT RED CONTAINERS HAD CHIPPED/DAMAGED BASE CORNERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "WHEN UNPACKING, THE BASE WAS FOUND TO BE DAMAGED (CHIPPED) AT ITS CORNER."

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, (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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SHARPS COLL 1QT RED CONTAINERS HAD CHIPPED/DAMAGED BASE CORNERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN UNPACKING, THE BASE WAS FOUND TO BE DAMAGED (CHIPPED) AT ITS CORNER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242877 SHARPS COLL 1QT RED HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305635 0171909 00382903056354

    Patients

    Seq Age Sex Outcome Treatment
    1