BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SHARPS COLLECTOR 8QT NEST OPEN TOP NEEDL PORT

    MDR report key: 14944355 · Received July 7, 2022

    Report

    Report Number
    2243072-2022-00900
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    June 7, 2022
    Report Date
    June 23, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903053433
    PMA / PMN Number
    K943134
    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. INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED. ADDITIONAL ATTEMPT TO GET MORE INFORMATION WAS MADE, HOWEVER, THE CUSTOMER CONFIRMED THAT NO ADDITIONAL INFORMATION WAS AVAILABLE. ACCORDING TO THE DHR REVIEW PROCESS, THE RESULTS SHOWED THERE WERE NO ISSUES REPORTED LIKE LID BROKEN OR DAMAGED DURING THE MANUFACTURING PROCESS FOR THE LOT NUMBER REPORTED (1252957) UNDER THIS CUSTOMER COMPLAINT. ALSO, A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE LID BROKEN OR DAMAGED (CRACKED) FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. BASED ON THE INFORMATION PROVIDED FROM CUSTOMER, THERE IS NOT ENOUGH EVIDENCE LIKE A PICTURE SHOWING THE DEFECT ON THE PRODUCT TO DETERMINE THE ROOT CAUSE, ONLY IN THE REPORT CUSTOMER DESCRIBES THAT ONE PRODUCT HAD A CRACK ON THE LID AND ALSO, WITH LOT NUMBER PROVIDED, IT CAN BE CONFIRMED THAT THIS PRODUCT WAS MANUFACTURED BY FLEX ON SEPTEMBER 9, 2021. ACCORDING WITH THIS INVESTIGATION, IT WAS NOTICED THAT THIS ISSUE AROSE FROM A PRODUCT SOLD IN JAPAN AND ALL THE SHIPPING AND TRANSPORTATION PROCESS FOR THAT COUNTRY PRODUCTS INDICATES THAT FLEX IS IN CHARGE OF MANUFACTURING, PACKAGING AND LOADING OF THE PRODUCT, WHILE BD IS IN CONTROL OF TRANSPORTATION, TRANSSHIPMENT, DISTRIBUTION AND FINAL DELIVERY. FOR THIS REASON, IT CAN BE CONCLUDED THAT PRODUCTS SOLD OUT OF USA GOES THROUGH DIFFERENT DISTRIBUTION STAGES WHERE THIS KIND OF ISSUE MAY BE GENERATED DUE TO HANDLING CARRIED OUT DURING THE TRANSPORTATION AND THOSE ACTIVITIES ARE OUT OF FLEX¿S REACH. CONSIDERING THAT FAILURE MODE IS RELATED TO BROKEN PARTS, THE MOLD WAS VERIFIED TO RULE OUT THAT THE ISSUE COULD BE GENERATED BY A DAMAGED ON THE MOLD, THE ASSESSMENT CONFIRMS THAT MOLD WAS FREE OF DAMAGES. BASED ON THAT ASSESSMENT, IT CAN BE CONFIRMED THAT THE ISSUE COULD BE GENERATED BY SEVERAL VARIABLES LIKE HIT, INCORRECT HANDLING, INCORRECT STORAGE OR NON-SUITABLE PACKAGING DURING PARTIAL SELLS. BASED ON INFORMATION PROVIDED IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE LIKE A FAILURE MODE RELATED TO THE MANUFACTURING PROCESS BECAUSE THERE IS NOT ENOUGH INFORMATION LIKE METHOD USED TO HANDLE, SHIPPED PARTIAL SELLS AND CONTROLS TO STORAGE THE REMAINING PRODUCT WITHIN DISTRIBUTOR FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED BD SHARPS COLLECTOR 8QT NEST OPEN TOP NEEDL PORT HAD A DAMAGED LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER'S. ¿THIS IS A REPORT ABOUT A CRACKED LID OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S REPORT, ONE PRODUCT HAD A CRACK ON THE LID.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2765797 BD SHARPS COLLECTOR 8QT NEST OPEN TOP NEEDL PORT HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 305343 1252957 50382903053433

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown