BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR

    MDR report key: 15820558 · Received November 17, 2022

    Report

    Report Number
    3003916417-2022-00259
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    September 20, 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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2090432, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2022-05-12, MEDICAL DEVICE LOT #: 2181405, MEDICAL DEVICE EXPIRATION DATE: 2023-06-30, DEVICE MANUFACTURE DATE: 2022-07-21. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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 (200) 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR THERE WAS STOPPER POP OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WHEN PERFORMING OPEN COLLECTIONS WITH TUBES OF SERUM GEL AND TRANSPORTING THE TUBES, DURING TRANSPORT THEY ARRIVE SPILLED. ROWS 7 & 8: STOPPER POP OFF IN BOTH BATCHES, AND DATE OF EVENT ON (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 THERE WAS STOPPER POP OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WHEN PERFORMING OPEN COLLECTIONS WITH TUBES OF SERUM GEL AND TRANSPORTING THE TUBES, DURING TRANSPORT THEY ARRIVE SPILLED. ROWS 7 & 8: STOPPER POP OFF IN BOTH BATCHES, AND DATE OF EVENT (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208084 BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown