BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD VACUTAINER TUBE

    MDR report key: 14983066 · Received July 11, 2022

    Report

    Report Number
    1024879-2022-00350
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    June 30, 2022
    Report Date
    July 19, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H6: INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: 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 FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE UNSPECIFIED BD VACUTAINER TUBE THE CAPS ARE COMING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE TOPS ARE COMING OFF THE TUBES. "THE RED TOP CAPS ARE COMING OFF ON OCCASION." D.1. MEDICAL DEVICE BRAND NAME: UNSPECIFIED BD VACUTAINER TUBE; D.3. MEDICAL DEVICE MANUFACTURER: FRANKLIN LAKES, NJ; D.4. MEDICAL DEVICE CAT #: UNKNOWN; D.4. UDI: UNKNOWN; D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. G.1. MANUFACTURING LOCATION: FRANKLIN LAKES, NJ. G.5. 510K: NA. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBE THE CAPS ARE COMING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE TOPS ARE COMING OFF THE TUBES. "THE RED TOP AND MUSTARD COLOR TOP" CAPS ARE COMING OFF ON OCCASION."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE UNSPECIFIED BD VACUTAINER TUBE THE CAPS ARE COMING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE TOPS ARE COMING OFF THE TUBES. "THE RED TOP CAPS ARE COMING OFF ON OCCASION."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE UNSPECIFIED BD VACUTAINER TUBE THE CAPS ARE COMING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE TOPS ARE COMING OFF THE TUBES. "THE RED TOP CAPS ARE COMING OFF ON OCCASION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016693 UNSPECIFIED BD VACUTAINER TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 366668 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown