BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 17442390 · Received August 2, 2023

    Report

    Report Number
    1024879-2023-00524
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 10, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678155
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED 3 SAMPLES FROM LOT# 2147731, 1 SAMPLE FROM LOT# 2161733, AND 1 SAMPLE FROM LOT# 2172196 IN ADDITION TO 1 PHOTO FOR INVESTIGATION. THE PHOTO AND CUSTOMER SAMPLES WAS REVIEWED AND THE INDICATED FAILURE MODE FOR ADDITIVE ABNORMALITY WAS NOT OBSERVED. ADDITIONALLY, 30 RETENTION SAMPLES FOR EACH LOT FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF ADDITIVE ABNORMALITY WAS OBSERVED ON LOTS 2147731 AND 2172196. NO ADDITIVE ABNORMALITY WAS OBSERVED ON LOT 2161733. 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 ADDITIVE ABNORMALITY FOR LOTS 2147731 AND 2172196 BUT UNCONFIRMED ON LOT 2161733. THE FOLLOWING ADDITIONAL LOT INFORMATION WAS CORRECTED: D4. MEDICAL DEVICE LOT #: 2147731 D4. MEDICAL DEVICE EXPIRATION DATE: 2023-10-31 H4. DEVICE MANUFACTURE DATE: 2022-05-27

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2161733. D4. MEDICAL DEVICE EXPIRATION DATE: 2023-10-31. H4. DEVICE MANUFACTURE DATE: 06/10/2022. D4. MEDICAL DEVICE LOT #: 2172196. D4. MEDICAL DEVICE EXPIRATION DATE: 2023-10-31. H4. DEVICE MANUFACTURE DATE: 2022-05-27. D4. MEDICAL DEVICE LOT #: 2172196. D4. MEDICAL DEVICE EXPIRATION DATE: 2023-11-30. H4. DEVICE MANUFACTURE DATE: 2022-06-21. H.3. 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 · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT THERE WAS DISCOLORED / ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTRIBUTOR, ON BEHALF OF CUSTOMER, REPORTS DISCOLORATION IN TUBING FOR CAT 367815 LOTS 2147731, 2172196, AND 2161733.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT THERE WAS DISCOLORED / ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTRIBUTOR, ON BEHALF OF CUSTOMER, REPORTS DISCOLORATION IN TUBING FOR CAT 367815 LOTS 2147731, 2172196, AND 2161733.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482151 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10 50382903678155

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown