BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 19311789 · Received May 14, 2024

    Report

    Report Number
    1024879-2024-00425
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 16, 2024
    Report Date
    July 22, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903679868
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3201199. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2024. H4. DEVICE MANUFACTURE DATE: 20-JUL-2023. D4. MEDICAL DEVICE LOT #: 3201200. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2024. H4. DEVICE MANUFACTURE DATE: 20-JUL-2023. 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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL: YES. D.9. RETURNED TO MANUFACTURER ON: 13-MAY-2024. INVESTIGATION SUMMARY: CATALOG NUMBER: 367986. BATCH NUMBER: 3201199. BD RECEIVED 12 SAMPLES AND 5 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODES OF HEMOLYSIS AND DAMAGED TUBE WERE OBSERVED. THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUES OF DAMAGED TUBE, GEL AIRBUBBLES, AND GEL STRINGS WERE OBSERVED. ADDITIONALLY, 30 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED AND NO ISSUES WERE OBSERVED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF APRIL 2024. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODES HEMOLYSIS, DAMAGED TUBE, GEL AIRBUBBLES, AND GEL STRINGS. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS. CATALOG NUMBER: 367986. BATCH NUMBER: 3201200. BD RECEIVED 5 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR GEL AIR BUBBLES WAS OBSERVED. ADDITIONALLY, 30 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF GEL AIR BUBBLES WAS NOT OBSERVED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE GEL AIR BUBBLES. 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 THAT 2000 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD ISSUES WITH CRACKED TUBES, GEL SMEARING, GEL AIR BUBBLES, AND/OR HEMOLYSIS. THERE WAS NO REPORT OF PATIENT IMPACT. AFFECTED LOTS: GEL AIR BUBBLES: 3201199 AND 3201200. CRACKED TUBES, GEL SMEARING, HEMOLYSIS: 3201199.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2000 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD ISSUES WITH CRACKED TUBES, GEL SMEARING, GEL AIR BUBBLES, AND/OR HEMOLYSIS. THERE WAS NO REPORT OF PATIENT IMPACT. AFFECTED LOTS: GEL AIR BUBBLES: 3201199 AND 3201200. CRACKED TUBES, GEL SMEARING, HEMOLYSIS: 3201199.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548378 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H10 30382903679868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown