BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM / CAT BLOOD COLLECTION TUBES

    MDR report key: 15413514 · Received September 13, 2022

    Report

    Report Number
    9617032-2022-00865
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 17, 2022
    Report Date
    July 15, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903678193
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    INVESTIGATION SUMMARY: MAT: 367819 LOT: 1350459 BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 20 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL 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 UNDERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM / CAT BLOOD COLLECTION TUBES DO NOT FILL CORRECTLY DURING SAMPLING, SEVERAL BATCHES BEING CONCERNED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿I HAVE A COMPLAINT REGARDING BD VACUTAINER PARTIC TUBES. SILICE CAP ROUGE, REFERENCES 369032/ 367819, LOTS 2040938/ 1350459. REPEATED INCIDENTS OCCURRED IN THE PNEUMOLOGY CONSULTATION DEPARTMENT: THE TUBES DO NOT FILL CORRECTLY DURING SAMPLING, SEVERAL BATCHES BEING CONCERNED. "

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM / CAT BLOOD COLLECTION TUBES DO NOT FILL CORRECTLY DURING SAMPLING, SEVERAL BATCHES BEING CONCERNED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿I HAVE A COMPLAINT REGARDING BD VACUTAINER PARTIC TUBES. SILICE CAP ROUGE, REFERENCES (B)(4). , LOTS 2040938/ 1350459. REPEATED INCIDENTS OCCURRED IN THE PNEUMOLOGY CONSULTATION DEPARTMENT: THE TUBES DO NOT FILL CORRECTLY DURING SAMPLING, SEVERAL BATCHES BEING CONCERNED. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534992 BD VACUTAINER® SERUM / CAT BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367819 1350459 50382903678193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown