BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST TUBE GEL 3.5 ML

    MDR report key: 12110889 · Received July 2, 2021

    Report

    Report Number
    9610048-2021-00100
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    June 8, 2021
    Report Date
    August 3, 2021
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT ONE (1) PHOTO AND TWO (2) VIDEOS WERE PROVIDED FOR INVESTIGATION. THE PHOTO AND VIDEOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR STOPPER POP OFF, STOPPER PULLOUT, AND TUBE PUSH OFF, WITH THE INCIDENT LOT WAS NOT OBSERVED. THE VIDEO SHOWED BLOOD COLLECTION THAT VARIED FROM BD'S PUBLISHED INSTRUCTIONS FOR USE (IFU). THE IFU STATES, "PUSH THE TUBE FORWARD UNTIL THE TUBE STOPPER HAS BEEN PENETRATED. IF CEASED, KEEP IN PLACE TO ENSURE COMPLETE COLLECTION UNDER VACUUM." ADDITIONALLY, EIGHT (8) RETENTION SAMPLES FROM BD FRANKLIN LAKES INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AT THE HOLDER MANUFACTURING SITE WITH THE MATCHING COMPLAINT HOLDER (MATERIAL NO. 364815, BATCH NO. 0030622). NO ISSUES WERE OBSERVED RELATING TO TUBE PUSH OFF AS ALL SAMPLES MET SPECIFICATIONS. SINCE THE ACQUISITION DEVICE IS NOT MANUFACTURED AT BD THE COMPATIBILITY OF THE NEEDLE IN RELATION TO THE HOLDER AND TUBE IS UNKNOWN. 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.SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER SST TUBE GEL 3.5 ML, THE DEVICE EXPERIENCED STOPPER POPS OUT OF THE TUBE, DIFFICULT/UNABLE TO PIERCE THROUGH STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: VERY OFTEN, CUSTOMER FINDS STOPPERS THAT ARE NOT ENTIRELY CLOSED, EXPOSING THE HEALTH PROFESSIONAL TO POTENTIALLY CONTAMINATED MATERIAL. IN SAMPLE DRAW MADE BY VACUUM, THE TUBES DON'T ADAPT PERFECTLY TO DEVICE, SOMETIMES IT RELEASES FROM THE SUPPORT (PULLOUT), INCREASING THE RISK OF PUNCTURE ACCIDENT. IT DOESN'T REGARD TO AN SPECIFIC BATCH, BUT TO GENERAL TUBES, MAINLY GEL. ONCE THE TUBE IS OPENED, IT'S HARDLY POSSIBLE TO CLOSE IT AGAIN (DIFFICULT TO INSERT STOPPER), AND WITH ANY MOVEMENT THE STOPPER POPS OFF AND MATERIAL LEAKS. INCLUDING NOT ONLY THE SAMPLE DRAW MOMENT, BUT ALSO WHEN OPENING THE TUBES TO PERFORM TESTS IN EQUIPMENT WITH A LATER RE-INSERTION OF THE YELLOW STOPPER FOR STORAGE.

    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 # : 1088684, MEDICAL DEVICE EXPIRATION DATE: 2022-03-31, DEVICE MANUFACTURE DATE: 2021-04-20. MEDICAL DEVICE LOT #: 1051620, MEDICAL DEVICE EXPIRATION DATE: 2022-02-28, DEVICE MANUFACTURE DATE: 2021-03-23 ". 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 WHEN USING THE BD VACUTAINER SST TUBE GEL 3.5 ML, THE DEVICE EXPERIENCED STOPPER POPS OUT OF THE TUBE, DIFFICULT/UNABLE TO PIERCE THROUGH STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: VERY OFTEN, CUSTOMER FINDS STOPPERS THAT ARE NOT ENTIRELY CLOSED, EXPOSING THE HEALTH PROFESSIONAL TO POTENTIALLY CONTAMINATED MATERIAL. IN SAMPLE DRAW MADE BY VACUUM, THE TUBES DON'T ADAPT PERFECTLY TO DEVICE, SOMETIMES IT RELEASES FROM THE SUPPORT (PULLOUT), INCREASING THE RISK OF PUNCTURE ACCIDENT. IT DOESN'T REGARD TO AN SPECIFIC BATCH, BUT TO GENERAL TUBES, MAINLY GEL. ONCE THE TUBE IS OPENED, IT'S HARDLY POSSIBLE TO CLOSE IT AGAIN (DIFFICULT TO INSERT STOPPER), AND WITH ANY MOVEMENT THE STOPPER POPS OFF AND MATERIAL LEAKS. INCLUDING NOT ONLY THE SAMPLE DRAW MOMENT, BUT ALSO WHEN OPENING THE TUBES TO PERFORM TESTS IN EQUIPMENT WITH A LATER RE-INSERTION OF THE YELLOW STOPPER FOR STORAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007564 BD VACUTAINER SST TUBE GEL 3.5 ML BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1