BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR

    MDR report key: 15814508 · Received November 17, 2022

    Report

    Report Number
    3003916417-2022-00260
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    September 22, 2022
    Report Date
    December 5, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT EIGHT (8) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR STOPPER POP OFF OR BREAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, TWO HUNDRED ((B)(4)) RETENTION SAMPLES FROM EACH LOT WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO STOPPER POP OFF OR BREAKAGE AS ALL SAMPLES MET SPECIFICATIONS. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    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 WHEN USING THE BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR THE STOPPER PULLED OUT OF TUBE WHEN IN AN ANALYZER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE HAVE PROBLEMS WITH THE TUBES WHEN CENTRIFUGING, WHICH STOPPERS ARE POPPING OFF AND THERE IS BLOOD SPILL AFTER TRANSPORT, CASES THAT HAVE NEVER OCCURRED BEFORE. A BATCH THAT THE ISSUE WAS OBSERVED IS 2090432. ROW 10: STOPPER POP OFF IN CENTRIFUGE FOR BATCH 2090432 AND DATE OF EVENT (B)(6)2022."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR THE STOPPER PULLED OUT OF TUBE WHEN IN AN ANALYZER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE HAVE PROBLEMS WITH THE TUBES WHEN CENTRIFUGING, WHICH STOPPERS ARE POPPING OFF AND THERE IS BLOOD SPILL AFTER TRANSPORT, CASES THAT HAVE NEVER OCCURRED BEFORE. A BATCH THAT THE ISSUE WAS OBSERVED IS 2090432. ROW 10: STOPPER POP OFF IN CENTRIFUGE FOR BATCH: 2090432 AND DATE OF EVENT ON (B)(6) 2022."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183014 BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 2090432

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown