BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NESTABLE NON-VENT SHARPS COLLECTOR

    MDR report key: 17177383 · Received June 21, 2023

    Report

    Report Number
    2243072-2023-01081
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    May 30, 2023
    Report Date
    July 20, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2133947. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: NA. D.4. MEDICAL DEVICE LOT #: 2209926. D.4. MEDICAL DEVICE EXPIRATION DATE. H.4. DEVICE MANUFACTURE DATE: NA. D.4. MEDICAL DEVICE LOT #: 2205911. D.4. MEDICAL DEVICE EXPIRATION DATE: NA . H.4. DEVICE MANUFACTURE DATE: 12-AUG-2022. D.4. MEDICAL DEVICE LOT #: 2268929. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: NA. D.4. MEDICAL DEVICE LOT #: 2145946. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: NA. D.4. MEDICAL DEVICE LOT #: 2233921. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: NA. D.4. MEDICAL DEVICE LOT #: 1342950. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: NA. D.4. MEDICAL DEVICE LOT #: 1352965. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: NA. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY CUSTOMER. BROKEN SHARPS CONTAINER LIDS ON ARRIVAL WAS NOT VERIFIED AS NO SAMPLE OR PHOTOS AVAILABLE. ACCORDING TO THE DEVICE HISTORY RECORD REVIEW, DURING THE MANUFACTURING PROCESS NO ISSUES WERE REPORTED FOR DAMAGED OR BROKEN LIDS FOR THE LOT NUMBERS 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. BASED ON THIS INVESTIGATION AND INFORMATION PROVIDED, CUSTOMER REPORTS BROKEN SHARPS CONTAINER LIDS ON ARRIVAL, HOWEVER, NO ADDITIONAL INFORMATION LIKE PICTURE OF THE DAMAGED PRODUCT OR ORIGINAL PACKAGE. ACCORDING WITH THIS INVESTIGATION, IT WAS NOTICED THAT THIS ISSUE AROSE FROM A PRODUCT SOLD IN AUSTRALIA 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, FIVE ADDITIONAL COMPLAINTS WERE RECEIVED THROUGH THE LAST TWELVE MONTHS FOR THE SAME PART NUMBER AND ISSUE. THESE PREVIOUS COMPLAINTS WERE CLOSED AS NON-MANUFACTURING BASED ON EVIDENCE RECEIVED SHOWING A DIFFERENT PRODUCT PACKAGE AND DUE TO AN UNKNOWN DISTRIBUTION 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 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. IF ADDITIONAL INFORMATION THAT HELPS TO FIND 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 ALSO FOR TRACKING AND TRENDING PURPOSES. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ NESTABLE NON-VENT SHARPS COLLECTORS ARRIVED BROKEN. LOT #'S 2133947, 2209926, 2268929, 2145946, 2233921, 1342950 AND 1352965. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN SHARPS CONTAINER LIDS ON ARRIVAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ NESTABLE NON-VENT SHARPS COLLECTORS ARRIVED BROKEN. LOT #'S 2133947, 2209926, 2268929, 2145946, 2233921, 1342950 AND 1352965 THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN SHARPS CONTAINER LIDS ON ARRIVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062163 BD¿ NESTABLE NON-VENT SHARPS COLLECTOR HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown