BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LARGE SHARPS CONTAINERS

    MDR report key: 16896725 · Received May 9, 2023

    Report

    Report Number
    2243072-2023-00770
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Date of Event
    April 18, 2023
    Report Date
    June 2, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PRODUCT WAS RETURNED BY THE CUSTOMER. PHOTOS REPRESENTATION WAS PROVIDED FOR THE COMPLAINT. AND LID BROKEN FROM THE CORNER WAS VERIFIED. ACCORDING TO THE DHR REVIEW, DURING THE MANUFACTURING PROCESS NO ISSUES WERE REPORTED FOR DAMAGED OR BROKEN LIDS FOR THE LOT NUMBER (2180941) REPORTED UNDER THIS COMPLAINT. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULTS EXHIBIT NO ISSUE REPORTED FOR THE SAME PART NUMBER AND ISSUE THROUGHOUT THE LAST TWELVE MONTHS. INVESTIGATION: BASED ON THE PICTURES AND INFORMATION PROVIDED BY CUSTOMER, IT CAN BE STATED THE FOLLOWING: THE LID IS CRACKED/DAMAGED FROM ONE CORNER. THE COLLECTOR BASE CONTAINS AN ADDITIONAL WHITE LABEL THAT IS UNKNOWN TO OUR PROCESS. WHICH MEANS THAT THIS PRODUCT HAS BEEN RELABELED BY THIRD PARTIES. THROUGH THE LOT NUMBER REPORTED, IT CAN BE CONFIRMED THAT THIS PRODUCT WAS MANUFACTURED BY FLEX ON JULY 2, 2022. ACCORDING WITH THIS INVESTIGATION, 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, IN CAN BE CONCLUDED THAT PRODUCTS SOLD OUT OF USA GOES THROUGH DIFFERENT DISTRIBUTION STAGES WHERE THIS KIND OF ISSUE MAY BE GENERATED DUE TO THE 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 DAMAGED. BASED ON THAT ASSESSMENT, IT CAN BE CONFIRMED THAT ISSUE COULD BE GENERATED BY SEVERAL VARIABLES LIKE HIT, INCORRECT HANDLING, INCORRECT STORAGE OR NON-SUITABLE PACKAGING DURING PARTIAL SELLS. BY OTHER HAND THE LIKELIHOOD TO SEND DAMAGED MATERIAL BY FLEX IS VERY LOW DUE TO THERE ARE SEVERAL CONTROLS TO VERIFY THIS KIND OF ISSUES. BECAUSE OF THIS, ADDITIONAL INFORMATION IS NEEDED ABOUT THE HANDLING AND STORAGE WITHIN DISTRIBUTOR FACILITY TO RULE OUT THAT THIS ISSUE WAS GENERATED BY DISTRIBUTORS. AS PART OF THIS INVESTIGATION, A REVIEW OF CUSTOMER COMPLAINT RECORDS WAS PERFORMED; ACCORDING TO THE CC¿S RECORDS, TWO ADDITIONAL COMPLAINT WAS RECEIVED THROUGH THE LAST TWELVE MONTHS FOR THE SAME PART NUMBER AND ISSUE. THIS PREVIOUS COMPLAINT WAS CLOSED AS INCOMPLETE SINCE THERE WAS NOT ENOUGH EVIDENCE PROVIDED IN ORDER TO DETERMINE THE ROOT CAUSE AS RELATED TO THE MANUFACTURING PROCESS. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER POTENTIAL ROOT CAUSE WILL BE: PRODUCT DAMAGED DURING THE TRANSSHIPPED PROCESS MADE BY BD¿S SECOND PROVIDER. NON-CONTROLLED METHOD TO SHIP PARTIAL BOXES TO END USER. PRODUCT DAMAGED DURING THE SHIPMENT OR DISTRIBUTION. INCORRECT REPACKAGING AT THE TIME TO PERFORM PARTIAL SALES. CONCLUSION BASED ON INFORMATION PROVIDED IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE LIKE A FAILURE MODE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS NOT ENOUGH INFORMATION LIKE METHOD USED TO HANDLE, SHIPPED PARTIAL SELLS AND CONTROLS TO STORAGE THE REMAINING PRODUCT WITHIN DISTRIBUTOR FACILITY. THE CONTROLS WERE VERIFIED WITHIN THE MANUFACTURING PROCESS AND CONFIRMED AS CAPABLE TO DETECT BROKEN OR DAMAGED LIDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LARGE SHARPS CONTAINERS LID WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE INFORM YOU THAT YESTERDAY A 22.7 LT COLLECTOR WITH BREAKDOWNS ARRIVED AT OUR FACILITIES AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600075 BD LARGE SHARPS CONTAINERS HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 2180941

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown