BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD YELLOW 3L SHARPS COLLECTOR

    MDR report key: 17221316 · Received June 28, 2023

    Report

    Report Number
    2243072-2023-01138
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    June 7, 2023
    Report Date
    August 9, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 14-JUL-2023. H.6. INVESTIGATION SUMMARY: 1 SAMPLE RECEIVED FOR MAT# 300450 AND LOT# 2308931, AND IT'S VERIFIED THAT LID IS MISSING. ACCORDING TO THE DEVICE HISTORY RECORD REVIEW, DURING THE MANUFACTURING PROCESS NO ISSUES WERE REPORTED FOR MISSING COMPONENTS (LIDS) FOR THE LOT NUMBERS REPORTED UNDER THIS COMPLAINT (2308931, 3008977). 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: ACCORDING WITH THIS INVESTIGATION AND EVIDENCE PROVIDED FROM THE 12 SAMPLES RECEIVED, IT CAN BE MENTIONED THE FOLLOWING: ¿ NO LIDS WERE RECEIVED. ¿ CUSTOMER CONFIRMED THAT 11 SAMPLES WERE FROM LOT #3093955 AND 1 SAMPLE FROM LOT #2308931. ¿ PRODUCT WAS NOT IN ITS ORIGINAL PACKAGING. ¿ BASED ON LOT NUMBERS, IT¿S CONFIRMED THAT THESE PRODUCTS WERE MANUFACTURED BY FLEX ON APRIL 3, 2023 (LOT #3093955) AND NOVEMBER 7, 2022 (LOT #2308931). WITH THE COLLECTED INFORMATION, WE ARE ABLE TO CONFIRM THAT THIS ISSUE IT¿S NOT RELATED TO THE MANUFACTURING PROCESS SINCE THE STANDARD PACK FOR THIS PRODUCT IS 36 PIECES OF THE SAME LOT NUMBER AND THE BASES ARE PACKED IN 3 LAYERS OF 4 STACKS, WHILE THE LIDS ARE STACKED IN 9 UNITS IN AN ALTERNATE POSITION ON THE 36 BASES. 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, NO ADDITIONAL COMPLAINTS WERE RECEIVED THROUGH THE LAST TWELVE MONTHS FOR THE SAME PART NUMBER AND ISSUE BEING THIS CONSIDERED AN ISOLATED ISSUE. AS PER THE SAMPLE BEING RECEIVED, AN INVESTIGATION COULD BE PERFORMED, AND A ROOT CAUSE COULD BE DETERMINED AS POTENTIAL ROOT CAUSE: 1. NON-CONTROLLED METHOD TO SHIP PARTIAL BOXES TO END USER (RE-PACKAGING PROCESS). 2. 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), FURTHERMORE, THERE WERE FOUND ACCEPTABLE RECORDS FOR EVERY SINGLE BOX MANUFACTURED FOR THE LOT NUMBERS PROVIDED WITHIN THE WEIGHING SYSTEM RECORDS. 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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. B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD YELLOW 3L SHARPS COLLECTOR THE LIDS WERE MISSING ON 20 UNITS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THESE WERE 20 UNITS IN A CASE THAT WAS MISSING 20 LIDS OUT OF THE 36 UNITS. VENDOR ITEM #300450. MCKESSON ITEM #10678. QUANTITY#20.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD YELLOW 3L SHARPS COLLECTOR THE LIDS WERE MISSING ON 20 UNITS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THESE WERE 20 UNITS IN A CASE THAT WAS MISSING 20 LIDS OUT OF THE 36 UNITS. VENDOR ITEM #300450. MCKESSON ITEM #10678. QUANTITY#20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571498 BD YELLOW 3L SHARPS COLLECTOR HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 3093955

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown