BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SHARPS COLLECTORS

    MDR report key: 17225810 · Received June 29, 2023

    Report

    Report Number
    2243072-2023-01148
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 7, 2023
    Report Date
    July 21, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY THE ACTUAL SAMPLE IS UNAVAILABLE FOR INVESTIGATION. PHOTO IS PROVIDED FOR VERIFICATION. ACCORDING TO THE DEVICE HISTORY RECORD REVIEW, DURING THE MANUFACTURING PROCESS NO ISSUES WERE REPORTED FOR DAMAGED OR BROKEN LIDS FOR THE LOT NUMBER REPORTED UNDER THIS COMPLAINT (2211921). 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. BASED ON THIS INVESTIGATION AND INFORMATION PROVIDED, CUSTOMER REPORTS 3 PIECES OF CRACKED LIDS UPON OPENING OF CARTON, THESE LIDS WERE FOUND IN BETWEEN A STACK OF LIDS, HOWEVER, NO ADDITIONAL INFORMATION LIKE PICTURE OF THE DAMAGED PRODUCT OR ORIGINAL PACKAGE WERE RECEIVED. ACCORDING WITH THIS INVESTIGATION, IT WAS NOTICED THAT THIS ISSUE AROSE FROM A PRODUCT SOLD IN SINGAPORE AND ALL THE SHIPPING AND TRANSPORTATION PROCESS FOR ASIA PACIFIC 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. AS PART OF THIS INVESTIGATION, A REVIEW OF CUSTOMER COMPLAINT RECORDS WAS PERFORMED; ACCORDING TO THE CC¿S RECORDS, NO ADDITIONAL COMPLAINTS WERE RECEIVED THROUGH THE LAST TWELVE MONTHS FOR THE SAME PART NUMBER AND ISSUE, BEING THIS CONSIDERED AN ISOLATED ISSUE. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD BE PERFORMED ON BASIS OF PHOTO REPRESENTATION, AND A ROOT CAUSE COULD BE DETERMINED AS POTENTIAL ROOT CAUSE AS BELOW: 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 BECAUSE 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.

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER:THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FLEXTRONICS. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(6) HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 OF THE BD SHARPS COLLECTORS HAD CRACKED LIDS. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: "WE FOUND 3PCS OF CRACKED LID UPON OPENING OF CARTON. THE CRACKED LIDS WERE FOUND IN BETWEEN A STACK OF LIDS. ."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 OF THE BD SHARPS COLLECTORS HAD CRACKED LIDS. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: "WE FOUND 3PCS OF CRACKED LID UPON OPENING OF CARTON. THE CRACKED LIDS WERE FOUND IN BETWEEN A STACK OF LIDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253681 BD SHARPS COLLECTORS HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 2211921

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown