BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE K2EDTA PLH 13X75 4.0 MLBL LAV CN

    MDR report key: 12625754 · Received October 13, 2021

    Report

    Report Number
    3006948883-2021-00966
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    September 15, 2021
    Report Date
    October 14, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. BD HAD NOT RECEIVED SAMPLES, BUT 5 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR MIXED PRODUCT WITH THE INCIDENT LOT WAS NOT OBSERVED. THE PHOTOS SHOW SKU367841 LOT# 0345753 PRODUCT IN THE BOX AND BOX LABEL SHOW SKU367230 LOT# 1082992. LOT# 0345753 SKU# 367841 WHICH MADE BY BROKEN BOW PLANT AND MANUFACTURE DATE IS JAN 2021;LOT# 1082992 SKU#367230 WHICH MADE BY SUZHOU PLANT AND MANUFACTURE DATE IS APR 2021. SUZHOU PLANT NOT IMPORT BROKEN BOW PLANT¿ PRODUCTS. SUZHOU PRODUCT WILL DELIVER TO SHANGHAI BAOSHAN WAREHOUSE AND BROKENBOW PRODUCT WILL DELIVER TO SHANGHAI WAIGAOQIAO WAREHOUSE WHICH IS DIFFERENT LOCATION. BASE ON ABOVE, THE MIXED CAN¿T HAPPENED AT MANUFACTURE SITE AND SHANGHAI DISTRIBUTION CENTER. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO MIXED PRODUCT AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE MIXED PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE TUBE K2EDTA PLH 13X75 4.0 MLBL LAV CN THERE WAS MIX OF PRODUCT TYPE IN A PACK. THIS EVENT OCCURRED 20 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "IT IS SUSPECTED THAT THE FLOW DIRECTION OF THIS BATCH OF BLOOD VESSELS IS FROM THE POSSIBILITY THAT THE IMPORT PIPE AND SUZHOU PIPE ARE MIXED INCORRECTLY WHEN THE MANUFACTURER IS PACKING. THE GOODS DELIVERED TO THE HOSPITAL IS 367230 AND THE QUANTITY IS 30,000. THE FEEDBACK IS THAT 367841 BATCH NO. 0345753 HAS NEVER BEEN PURCHASED. THEREFORE, AFTER OUR INVESTIGATION, NO 367841 OUTER PACKING BOXES WERE FOUND IN THE HOSPITAL WAREHOUSE.".

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED WHEN USING THE TUBE K2EDTA PLH 13X75 4.0 MLBL LAV CN THERE WAS MIX OF PRODUCT TYPE IN A PACK. THIS EVENT OCCURRED 20 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "IT IS SUSPECTED THAT THE FLOW DIRECTION OF THIS BATCH OF BLOOD VESSELS IS FROM THE POSSIBILITY THAT THE IMPORT PIPE AND SUZHOU PIPE ARE MIXED INCORRECTLY WHEN THE MANUFACTURER IS PACKING. THE GOODS DELIVERED TO THE HOSPITAL IS 367230 AND THE QUANTITY IS 30,000. THE FEEDBACK IS THAT 367841 BATCH NO. 0345753 HAS NEVER BEEN PURCHASED. THEREFORE, AFTER OUR INVESTIGATION, NO 367841 OUTER PACKING BOXES WERE FOUND IN THE HOSPITAL WAREHOUSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521805 TUBE K2EDTA PLH 13X75 4.0 MLBL LAV CN BLOOD SPECIMEN COLLECTION DEVICE JKA BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1082992

    Patients

    Seq Age Sex Outcome Treatment
    1