BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD CPT BLOOD COLLECTION TUBES

    MDR report key: 15421967 · Received September 14, 2022

    Report

    Report Number
    2243072-2022-01510
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    August 25, 2022
    Report Date
    July 15, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MAT: UNK, LOT: UNK. NO SAMPLES OR PHOTOS WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE MATERIAL NUMBER AND THE LOT NUMBER ARE UNKNOWN. THE PROCEDURE STATED IN THE IFU FOR CPT TUBE WITH SODIUM CITRATE SHOULD BE AT ROOM TEMPERATURE (18°-25°C). DRY ICE IS A SOLID. IT SUBLIMATES OR CHANGES STATE FROM A SOLID TO A GAS AT TEMPERATURES OF -78 DEGREES CELSIUS UNDER NORMAL ATMOSPHERIC PRESSURE OF 1 ATM. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE NO SAMPLES OR PHOTOS WERE RETURNED, AND MATERIAL AND LOT NUMBERS ARE UNKNOWN. LOT NUMBER IS UNKNOWN; THEREFORE, NO RETENTION SAMPLES ARE AVAILABLE. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. 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 UNSPECIFIED BD CPT BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED CRACKED TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "TIME DEPENDENT CHANGES IN THE BIOENERGETICS OF PERIPHERAL BLOOD MONONUCLEAR CELLS: PROCESSING TIME, COLLECTION TUBES AND CRYOPRESERVATION EFFECTS" REPORTING CPT WITH SODIUM CITRATE TUBES CRACKING WHEN STORED WITH DRY ICE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE UNSPECIFIED BD CPT BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED CRACKED TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "TIME DEPENDENT CHANGES IN THE BIOENERGETICS OF PERIPHERAL BLOOD MONONUCLEAR CELLS: PROCESSING TIME, COLLECTION TUBES AND CRYOPRESERVATION EFFECTS" REPORTING CPT WITH SODIUM CITRATE TUBES CRACKING WHEN STORED WITH DRY ICE.S

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609416 UNSPECIFIED BD CPT BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown