BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 9751328 · Received February 25, 2020

    Report

    Report Number
    9617032-2020-00168
    Event Type
    Malfunction
    Date Received
    February 25, 2020
    Date of Event
    February 4, 2020
    Report Date
    April 29, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-02-26. H.6. 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 UNDERFILL WITH THE INCIDENT LOT WAS OBSERVED. THE CUSTOMER SAMPLES (LOT 9242646) WERE DRAW TESTED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR UNDERFILL AND TUBE PUSH OFF WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES FROM LOTS 9242646, 9127582 AND 9189859 WERE SELECTED FROM BD INVENTORY FOR TESTING AND UPON COMPLETION, THE ISSUE RELATING TO UNDERFILL WAS NOT OBSERVED. DRAW TESTING WAS PERFORMED AND IT WAS DETERMINED THAT ALL TUBES DREW WITHIN SPECIFICATION. ALL TUBE CAP/STOPPER ASSEMBLIES WERE REMOVED, AND THEN RE-ATTACHED. THE CAP/STOPPERS WERE EASY TO FIX BACK ON THE TUBES, AND NO STOPPERS POPPED OFF THEIR TUBES DURING THE NEXT 4 HOURS. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TUBES ARE UNDER FILLING AND PUSHING OFF NON-PATIENT END OF NEEDLE WITH A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES. TUBES PUSHING OFF NEEDLE OCCURRED ON 5 SEPARATE OCCASIONS DURING USE WITH EACH BATCH, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 3 COMPLAINTS) TUBES JUMP AND REBOUND IN THE HOLDER. TUBES ARE UNDER FILLED.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9127582. MEDICAL DEVICE EXPIRATION DATE: 2020-11-30. DEVICE MANUFACTURE DATE: 2019-05-07. MEDICAL DEVICE LOT #: 9189859. MEDICAL DEVICE EXPIRATION DATE: 2020-12-31. DEVICE MANUFACTURE DATE: 2019-07-08. MEDICAL DEVICE LOT #: 9242646. MEDICAL DEVICE EXPIRATION DATE: 2021-02-28. DEVICE MANUFACTURE DATE: 2019-08-30." 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 TUBES ARE UNDER FILLING AND PUSHING OFF NON-PATIENT END OF NEEDLE WITH A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES. TUBES PUSHING OFF NEEDLE OCCURRED ON 5 SEPARATE OCCASIONS DURING USE WITH EACH BATCH, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 3 COMPLAINTS) TUBES JUMP AND REBOUND IN THE HOLDER. TUBES ARE UNDER FILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216140 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other