BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E / K2 EDTA BLOOD COLLECTION TUBES

    MDR report key: 17440551 · Received August 2, 2023

    Report

    Report Number
    1917413-2023-00712
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 14, 2023
    Report Date
    October 19, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. INITIAL REPORTER PHONE #: (B)(6).

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL #368171, BATCH# 3111843. BD HAD NOT RECEIVED SAMPLES BUT 2 PHOTOS WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT FROM CATALOG 368171, LOT 3111843. THE PHOTOS WERE EVALUATED AND ONE PHOTO SHOWS 9 SHELF PACKS FROM CATALOG 368171, LOT 2347106 AND 1 SHELF PACK FROM CATALOG 368171, LOT 3111843. CATALOG 368171, LOT 2347106 WAS MANUFACTURED IN 26JAN2023 AND CATALOG 368171, LOT 3111843 WAS MANUFACTURED IN 17MAY2023. ONE OF THE PHOTOS OF THE CASE DOES APPEAR THAT THE CASE HAS BEEN TAPED OVER AS THE TAPE IS WRINKLED AT THE TOP OF THE PHOTO. PER PROCEDURE, LINE CLEARANCE, EACH INDIVIDUAL MANUFACTURING STATION/WORK CENTER WILL BE CLEARED OF CURRENTLY RUNNING PRODUCT PRIOR TO COMMENCING MANUFACTURE OF THE NEXT SCHEDULED PRODUCTION BATCH THROUGH THAT STATION/WORK CENTER. THESE TWO LOTS WERE PRODUCED ON THE SAME LINE; HOWEVER, THE MANUFACTURING DATES ARE 4 MONTHS APART. WITH OUR CURRENT LINE CLEARANCE PROCEDURE, MIXED PRODUCT COULD NOT HAVE COME FROM THE MANUFACTURING SITE. THIS CATALOG, 368171, SHIPS TO MEXICO VIA (B)(6). LOT 2347106 WAS ALL SHIPPED IN FEBRUARY OF 2023, LOT 3111843 WAS ALL SHIPPED IN MAY OF 2023. ALL PRODUCTS RAN THROUGH STERILIZATION IS LOADED ONTO A TRAILER BY ITSELF AS THIS IS THE ONLY PRODUCT THAT IS SHIPPED TO MEXICO ON A MONTHLY BASIS, SO EACH LOT WILL BE SHIPPED ALL TOGETHER. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE PHOTOS PROVIDED; HOWEVER, THE MIXED PRODUCT DID NOT COME FROM THE MANUFACTURING PLANT IN THIS MANNER. THE EXACT CAUSE FOR THE CUSTOMER¿S FAILURE MODE COULD NOT BE DETERMINED WITH THE INVESTIGATION COMPLETED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E / K2 EDTA BLOOD COLLECTION TUBES CUSTOMER REPORTS THAT 9 SHELF PACKS INSIDE OF IT REGARD TO A DIFFERENT BATCH. THIS EVENT OCCURRED 9 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ONCE THE SHIPPING CARTON WAS RECEIVED, IT WAS NOTED THAT 9 SHELF PACKS INSIDE OF IT REGARD TO A DIFFERENT BATCH. SHIPPING CARTON LABEL BATCH: 3111843. SHELF CARTON LABEL BATCH: 2347106.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E / K2 EDTA BLOOD COLLECTION TUBES CUSTOMER REPORTS THAT 9 SHELF PACKS INSIDE OF IT REGARD TO A DIFFERENT BATCH. THIS EVENT OCCURRED 9 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ONCE THE SHIPPING CARTON WAS RECEIVED, IT WAS NOTED THAT 9 SHELF PACKS INSIDE OF IT REGARD TO A DIFFERENT BATCH. SHIPPING CARTON LABEL BATCH: 3111843; SHELF CARTON LABEL BATCH: 2347106.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772583 BD VACUTAINER® K2E / K2 EDTA BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3111843

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown