BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ EXTRA LARGE SHARPS COLLECTOR SLIDE TOP, 19 GAL, RED

    MDR report key: 17700431 · Received September 7, 2023

    Report

    Report Number
    2243072-2023-01590
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 14, 2023
    Report Date
    October 5, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903056095
    PMA / PMN Number
    K943575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: 5 SAMPLE(S) RECEIVED FROM CUSTOMER FOR FURTHER INVESTIGATION AND EVIDENCE SENT TO MANUFACTURER FOR FURTHER EVALUATION. ACCORDING TO THE DHR REVIEW PROCESS, THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE MISSING LIDS DURING THE MANUFACTURING PROCESS FOR THE LOT NUMBER (3185937) REPORTED UNDER THIS CUSTOMER COMPLAINT. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED NO ISSUE REPORTED FOR MISSING LIDS FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. INVESTIGATION: BASED ON THE INFORMATION AND PICTURES PROVIDED AS EVIDENCE, IT CAN BE STATED THE FOLLOWING: THE MISSING COMPONENT CANNOT BE SEEN IN THE IMAGES, HOWEVER, WITHIN GLOBAL CUSTOMER COMPLAINT REPORT, IT¿S MENTIONED THAT THERE WAS NO LID. BASED ON THE LOT NUMBER PROVIDED, IT¿S CONFIRMED THAT THIS PRODUCT WAS MANUFACTURED BY FLEX ON JULY 4, 2023. AS PART OF THE STANDARD PACKAGING ESTABLISHED WITHIN OUR PROCESS, THE LIDS ARE PACKAGED IN SETS OF 5 LIDS, WHICH ARE GROUPED WITH A PLASTIC STRAP, THIS MEANS THAT PRODUCT COULD HAD BEEN HANDLED. BASED ON THE COLLECTED INFORMATION, THE ROOT CAUSE OF THIS ISSUE CANNOT BE DETERMINED SINCE THE VARIABLES THAT COULD GENERATE THIS FAILURE MODE SUCH AS HANDLING, TRANSPORTATION, STORAGE OR PARTIAL SALES ARE UNKNOWN. ADDITIONAL INFORMATION IS REQUIRED TO DISCARD ISSUE WAS GENERATED BY A DISTRIBUTOR FACILITY, SINCE PARTIAL SELLS AND CONTROLS TO HANDLE REMAINING MATERIAL IS UNKNOWN, THEREFORE, THE LIKELIHOOD OF SENDING BOXES WITH INCORRECT QUANTITY EXIST. IN ADDITION, THE CURRENT MANUFACTURING CONTROLS WERE REVIEWED, AND CONFIRMED THE CAPABILITY TO DETECT THIS TYPE OF ISSUE (MISSING LIDS). AS PART OF THIS INVESTIGATION, A REVIEW OF CUSTOMER COMPLAINT RECORDS WAS PERFORMED; ACCORDING TO THE CC¿S RECORDS, FIVE ADDITIONAL COMPLAINTS WERE RECEIVED THROUGH THE LAST TWELVE MONTHS FOR THE SAME PART NUMBER AND ISSUE. THERE PREVIOUS COMPLAINTS WERE CLOSED AS INCOMPLETE SINCE THERE WAS NOT ENOUGH INFORMATION PROVIDED. WEIGHT RECORDS: THE WEIGHING DATABASE WAS EVALUATED TO CONFIRM THAT EVERY BOX MANUFACTURED UNDER THE LOT NUMBER REPORTED WAS PACKAGE WITH THE CORRECT QUANTITY OF LIDS AT THE TIME TO PERFORM THE PACKING PROCESS. ACCORDING TO THE REVIEW OF EVERY RECORD FOR WEIGHTED BOXES, IT WAS SUMMARIZED THE FOLLOWING: THE LOT 3185937, IT WAS BUILT FOR (B)(4) UNITS WITH A STANDARD PACK OF 5 UNITS PER BOX, WITH A TOTAL OF (B)(4) BOXES. THERE WERE FOUND ACCEPTABLE RECORDS FOR EVERY SINGLE BOX MANUFACTURED IN THIS LOT. ALL THE 354 WEIGHT RECORDS WERE GREATER THAN THE LOWEST VALIDATED LIMIT SET IN THE WEIGHING SYSTEM. AS PER THE SAMPLE BEING RECEIVED, AN INVESTIGATION COULD BE PERFORMED, AND A ROOT CAUSE COULD BE DETERMINED AS POTENTIAL ROOT CAUSE: NON-CONTROLLED METHOD TO SHIP PARTIAL BOXES TO END USER (RE-PACKAGING PROCESS). NON-CONTROLLED HANDLING WITHIN DISTRIBUTOR FACILITIES. CONCLUSION: BASED ON INFORMATION PROVIDED IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE LIKE A FAILURE MODE RELATED TO THE MANUFACTURING PROCESS SINCE INFORMATION SUCH AS METHOD USED TO HANDLE, SHIPPED PARTIAL SELLS AND CONTROLS TO STORAGE THE REMAINING PRODUCT WITHIN DISTRIBUTOR FACILITY IS UNKNOWN. THE CONTROLS WERE VERIFIED WITHIN THE MANUFACTURING PROCESS AND CONFIRMED AS CAPABLE TO DETECT THE REPORTING FAILURE MODE (MISSING LIDS). ADDITIONALLY, ACCEPTABLE RECORDS WERE FOUND FOR EACH BOX MANUFACTURED OF THE LOT NUMBER REPORTED UNDER THIS CUSTOMER COMPLAINT DURING THE REVIEW OF THE WEIGHING SYSTEM RECORDS (GREATER THAN THE LOWEST VALIDATED LIMIT UNDER THE WEIGHING SYSTEM). IF ADDITIONAL INFORMATION THAT WOULD HELP TO DETERMINE THE ROOT CAUSE CAN BE PROVIDED, THEN A NEW COMPLAINT RECORD WILL BE OPEN TO INITIATE A NEW INVESTIGATION PATH. ALL THE COMPLAINT INFORMATION WAS CAPTURED FOR TRACKING AND TRENDING PURPOSES. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    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 FRANKLIN LAKES, NJ 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. H.4. DEVICE MANUFACTURE DATE: NONE. 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 THE BD¿ EXTRA LARGE SHARPS COLLECTOR SLIDE TOP, 19 GAL, RED HAD NO LIDS. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: INJURIES OR ADVERSE EVENT: NO. REPORTED ISSUE: NO LIDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD¿ EXTRA LARGE SHARPS COLLECTOR SLIDE TOP, 19 GAL, RED HAD NO LIDS. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: INJURIES OR ADVERSE EVENT: NO. REPORTED ISSUE: NO LIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038698 BD¿ EXTRA LARGE SHARPS COLLECTOR SLIDE TOP, 19 GAL, RED HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 3185937 00382903056095

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown