BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® C&S TRANSFER STRAW KIT

    MDR report key: 17131214 · Received June 14, 2023

    Report

    Report Number
    1917413-2023-00546
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 23, 2023
    Report Date
    July 11, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JSM
    UDI-DI
    50382903649537
    PMA / PMN Number
    K024240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 3032561. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2023-02-01. MEDICAL DEVICE LOT #: 3005271. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2023-01-05.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES D9: RETURNED TO MANUFACTURER ON: 6-29-2023 H.6 INVESTIGATION SUMMARY MATERIAL # [364953 LOT/ BATCH # [ 3005271 AND 3032561] BD RECEIVED (1) SAMPLE FROM LOT 303256 AND (6) PHOTOS WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT FROM CATALOG 364953, LOT NUMBERS 3005271 AND 3032561. VISUAL EXAMINATION OF THE SAMPLE AND PHOTOS WAS PERFORMED AND REVEALED THE PRESENCE OF SEPARATION. THE SAMPLE AND PHOTOS SHOW THE HOLDER HAS BECOME SEPARATED FROM THE STRAW AND NEEDLE ASSEMBLY. REGULAR INSPECTIONS FOR THE ADHESIVE BOND WHERE THE BOND WILL NOT BE BROKEN WITH A SPECIFIC FORCE. THE UV SENSOR IS CHALLENGED TO MAKE SURE THE GLUE IS CURED. ADDITIONALLY, (10) RETENTION SAMPLES FROM BOTH LOTS WERE INSPECTED WITH NO NEEDLE SEPARATION IDENTIFIED. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE SAMPLE AND PHOTOS PROVIDED. THE EXACT CAUSE OF THE FAILURE MODE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORDS FROM BOTH LOTS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. 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 BD VACUTAINER® C&S TRANSFER STRAW KIT CUSTOMER REPORTED THAT THE STRAW IS LOOSE AND IS POKING THROUGH THE PLASTIC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE PORTION OF TRANSFER STRAW LOOSE AND POKING THROUGH THE PLASTIC. CUSTOMER REPORTS NEEDLE PORTION OF TRANSFER STRAW LOOSE AND POKING THROUGH THE PLASTIC FOR CAT 364953 LOT 3032561."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® C&S TRANSFER STRAW KIT CUSTOMER REPORTED THAT THE STRAW IS LOOSE AND IS POKING THROUGH THE PLASTIC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE PORTION OF TRANSFER STRAW LOOSE AND POKING THROUGH THE PLASTIC. CUSTOMER REPORTS NEEDLE PORTION OF TRANSFER STRAW LOOSE AND POKING THROUGH THE PLASTIC FOR CAT 364953 LOT 3032561."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946001 BD VACUTAINER® C&S TRANSFER STRAW KIT TRANSPORT CULTURE MEDIUM JSM BECTON, DICKINSON & CO. (BROKEN BOW) 364953 SEE H.10 50382903649537

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown