BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 10976882 · Received December 9, 2020

    Report

    Report Number
    9617032-2020-01010
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 17, 2020
    Report Date
    January 7, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679534
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED FROM THE 3 LOTS BY FUNCTIONAL TESTING AND THE ISSUE OF TUBE PUSH OFF WAS NOT OBSERVED. THIS TYPE OF DEFECT MAY OCCUR DUE TO THE RESILIENCE OF THE SLEEVE AND / OR THE LEVEL OF LUBRICATION OF THE NP NEEDLE. 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 NON-CONFORMANCE'S DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES EXPERIENCED WHOLE TUBE PUSH OFF NON-PATIENT END OF NEEDLE. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED "WHEN WE PUSH THE TUBE INTO THE HOLDER AND IT IS PIERCED BY THE NEEDLE (BLOOD FLOWS INTO THE TUBE), WE MUST ABSOLUTELY KEEP THE TUBE PRESSED WITH YOUR THUMB. IF WE DON'T, THE TUBE POPS OUT OF THE NEEDLE AND HOLDER IN A TOTALLY RANDOM FASHION.".

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0248557, MEDICAL DEVICE EXPIRATION DATE: 2022-03-31, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0240262, MEDICAL DEVICE EXPIRATION DATE: 2022-02-28, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0240258, MEDICAL DEVICE EXPIRATION DATE: 2022-02-28, DEVICE MANUFACTURE DATE: (B)(6) 2020. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES EXPERIENCED WHOLE TUBE PUSH OFF NON-PATIENT END OF NEEDLE. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED "WHEN WE PUSH THE TUBE INTO THE HOLDER AND IT IS PIERCED BY THE NEEDLE (BLOOD FLOWS INTO THE TUBE), WE MUST ABSOLUTELY KEEP THE TUBE PRESSED WITH YOUR THUMB. IF WE DON'T, THE TUBE POPS OUT OF THE NEEDLE AND HOLDER IN A TOTALLY RANDOM FASHION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443563 BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367953 0240258 50382903679534

    Patients

    Seq Age Sex Outcome Treatment
    1