BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8730826 · Received June 25, 2019

    Report

    Report Number
    1024879-2019-01048
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    June 10, 2019
    Report Date
    July 26, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR THE DISCOLORED CAP, CAP EMBEDDED WITH FOREIGN MATTER, PRINTING DEFECT, AIR BUBBLE IN GEL, DAMAGED HEMOGARD SHIELD AND FOREIGN MATTER IN GEL WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND ALL OF THE INDICATED FAILURE MODES WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THE FOREIGN MATTER IN GEL ISSUE THROUGH CAPA #503254 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR DISCOLORED CAP, CAP EMBEDDED WITH FOREIGN MATTER, PRINTING DEFECT, AIR BUBBLE IN GEL, DAMAGED HEMOGARD SHIELD AND FOREIGN MATTER IN GEL WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS CONDUCTED AND ALL OF THE INDICATED FAILURE MODES WAS OBSERVED. FURTHER INVESTIGATION HAS BEEN INITIATED FOR FOREIGN MATTER IN GEL THROUGH CAPA #503254. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES HAVE BEEN IDENTIFIED TO MITIGATE FURTHER OCCURRENCES. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE FOR THE CUSTOMER¿S INDICATED FAILURE MODE FOR DISCOLORED CAP, CAP EMBEDDED WITH FOREIGN MATTER, PRINTING DEFECT, AIR BUBBLE IN GEL AND DAMAGED HEMOGARD SHIELD WAS DETERMINED TO BE RELATED TO A MANUFACTURING ISSUE. CAPA #503254 WAS CONDUCTED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED THE MOST LIKELY ROOT CAUSES AND CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THE FOREIGN MATTER IN GEL. THE INVESTIGATION HAS IDENTIFIED POTENTIAL ROOT CAUSE(S) FOR THIS ISSUE AND CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 53 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD FOREIGN MATTER IN THE GEL, 1 TUBE WAS DAMAGED, 226 TUBES HAD SCALE MARKING DISCREPANCIES, 4 TUBES HAD FOREIGN MATTER EMBEDDED IN THE SHIELDS, 1 TUBE HAD FOREIGN MATTER EMBEDDED IN IT, 14 TUBES WERE "DIRTY" WITH INK, 654 TUBES HAD AIR BUBBLES IN THE GEL, 6 TUBES HAD DISCOLORED SHIELDS, AND 1 TUBE HAD FADED SCALE MARKINGS. ALL DEFECTS OCCURRED FROM LOT # 9003749, AND ALL WERE FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "FM IN THE TUBE X4, FM IN THE GEL X53, DAMAGED TUBE X1, PRINTING DEFECT X226, DIRTY CAP X4, BLACK SPOTS X4, DIRTY TUBE X14, AIR BUBBLES IN GELS X 654, DISCOLORED CAP X6 PRINTING FADE OFF X1".

    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 THAT 53 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD FOREIGN MATTER IN THE GEL, 1 TUBE WAS DAMAGED, 226 TUBES HAD SCALE MARKING DISCREPANCIES, 4 TUBES HAD FOREIGN MATTER EMBEDDED IN THE SHIELDS, 1 TUBE HAD FOREIGN MATTER EMBEDDED IN IT, 14 TUBES WERE "DIRTY" WITH INK, 654 TUBES HAD AIR BUBBLES IN THE GEL, 6 TUBES HAD DISCOLORED SHIELDS, AND 1 TUBE HAD FADED SCALE MARKINGS. ALL DEFECTS OCCURRED FROM LOT # 9003749, AND ALL WERE FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "FM IN THE TUBE X4, FM IN THE GEL X53, DAMAGED TUBE X1, PRINTING DEFECT X226, DIRTY CAP X4, BLACK SPOTS X4, DIRTY TUBE X14, AIR BUBBLES IN GELS X 654, DISCOLORED CAP X6, PRINTING FADE OFF X1."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526156 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9003749

    Patients

    Seq Age Sex Outcome Treatment
    1 Other