BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SERUM BLOOD COLLECTION TUBES

    MDR report key: 11499563 · Received March 16, 2021

    Report

    Report Number
    1024879-2021-00182
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 24, 2021
    Report Date
    March 22, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903666688
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/1/2021. H.6. INVESTIGATION: BD RECEIVED 64 SAMPLES OF MATERIAL 366668, BATCH 0121033 FOR INVESTIGATION. FOUR SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND 60 SAMPLES WERE EVALUATED BY DRAW TESTING AND THE INDICATED FAILURE MODE FOR LOW DRAW VOLUME WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. ALL RETENTION SAMPLES MET SPECIFICATION REQUIREMENT WHEN TESTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER CALLED IN TO REPORTED ISSUES OF UNDER-FILLING. SHE STATED THERE IS LITTLE TO NO VACUUM. NO DATE OF EVENT, NO SPECIFIC NUMBER OF OCCURRENCES, NO ERRONEOUS RESULTS AND NO MEDICAL INTERVENTION. CUSTOMER CONFIRMED UNUSED SAMPLES ARE AVAILABLE FOR INVESTIGATION. 24-FEB-2021: BD TECH BARBARA CARSON, - "SPOKE WITH THE CUSTOMER. SHE STATED THAT ALL 35 TUBES IN THIS LOT HAVE HAD LITTLE OR NO VACUUM AT ALL, WHEN USING A STRAIGHT NEEDLE. THEY ARE NOW USING DIFFERENT LOT #S AND ARE NOT SEEING ANY VACUUM ISSUES. SHE WILL SEND IN SAMPLES.".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER CALLED IN TO REPORTED ISSUES OF UNDER-FILLING. SHE STATED THERE IS LITTLE TO NO VACUUM. NO DATE OF EVENT, NO SPECIFIC NUMBER OF OCCURRENCES, NO ERRONEOUS RESULTS AND NO MEDICAL INTERVENTION. CUSTOMER CONFIRMED UNUSED SAMPLES ARE AVAILABLE FOR INVESTIGATION. (B)(6), - "SPOKE WITH THE CUSTOMER. SHE STATED THAT ALL 35 TUBES IN THIS LOT HAVE HAD LITTLE OR NO VACUUM AT ALL, WHEN USING A STRAIGHT NEEDLE. THEY ARE NOW USING DIFFERENT LOT #S AND ARE NOT SEEING ANY VACUUM ISSUES. SHE WILL SEND IN SAMPLES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394968 BD VACUTAINER SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 366668 0121033 50382903666688

    Patients

    Seq Age Sex Outcome Treatment
    1