BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD VACUTAINER BLOOD COLLECTION TUBE

    MDR report key: 12339767 · Received August 18, 2021

    Report

    Report Number
    9617032-2021-00904
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    August 4, 2021
    Report Date
    September 7, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIVE INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER. THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE UNSPECIFIED BD VACUTAINER BLOOD COLLECTION TUBE THE STOPPER POPS OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE NP SLEEVE PUSHES THE TUBE OUT OF THE HOLDER, POPS THE TUBE OUT IF NOT HELD DOWN." D.1. MEDICAL DEVICE BRAND NAME: UNSPECIFIED BD VACUTAINER BLOOD COLLECTION TUBE. D.2. MEDICAL DEVICE CATALOG#: UNKNOWN. D.2. MEDICAL DEVICE TYPE: NA. D.2. MEDICAL DEVICE LOT#: UNKNOWN. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. D.5. UNIQUE IDENTIFIER (UDI) #: UNKNOWN. G.2. MANUFACTURING LOCATION: BECTON DICKINSON. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.10 MANUFACTURER NARRATIVE: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE UNSPECIFIED BD VACUTAINER BLOOD COLLECTION TUBE THE STOPPER POPS OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE NP SLEEVE PUSHES THE TUBE OUT OF THE HOLDER, POPS THE TUBE OUT IF NOT HELD DOWN."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBE THE STOPPER POPS OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE NP SLEEVE PUSHES THE TUBE OUT OF THE HOLDER, POPS THE TUBE OUT IF NOT HELD DOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233400 UNSPECIFIED BD VACUTAINER BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1