BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOG¿ BC YEL 24GA X 0.75IN

    MDR report key: 8697325 · Received June 13, 2019

    Report

    Report Number
    1710034-2019-00621
    Event Type
    Injury
    Date Received
    June 13, 2019
    Date of Event
    March 5, 2019
    Report Date
    August 5, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825128
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE PHOTOGRAPHS PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO IDENTIFY OR CONFIRM THE ALLEGED FAILURE OR TO ESTABLISH A DEFINITE ROOT CAUSE. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF BATCH NUMBERS: 6274633 AND 7131506. 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 THAT DURING USE THE NEEDLE TIP BROKE OFF AND LODGED UNDER THE PATIENTS SKIN WITH A BD INSYTE¿ AUTOG¿ BC YEL 24GA X 0.75IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 382512, BATCH NO. ALLEGEDLY 6274633 OR 7131506. IT WAS REPORTED THAT THE NEEDLE TIP BROKE OFF AND LODGED UNDER THE PATIENTS SKIN. DATE OF INJURY: (B)(6) 2019 02:30PM.

    Additional Manufacturer Narrative · 1

    TWO POTENTIAL LOT NUMBER WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT # IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6274633, MEDICAL DEVICE EXPIRATION DATE: 2019-09-30, DEVICE MANUFACTURE DATE: 2019-10-03. MEDICAL DEVICE LOT #: 7131506, MEDICAL DEVICE EXPIRATION DATE: 2020-04-30, DEVICE MANUFACTURE DATE: 2017-05-12. DEVICE EVALUATED BY MFR: 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 THAT DURING USE THE NEEDLE TIP BROKE OFF AND LODGED UNDER THE PATIENTS SKIN WITH A BD INSYTE¿ AUTOG¿ BC YEL 24GA X 0.75IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382512, BATCH NO.: ALLEGEDLY 6274633 OR 7131506. IT WAS REPORTED THAT THE NEEDLE TIP BROKE OFF AND LODGED UNDER THE PATIENT'S SKIN. DATE OF INJURY: (B)(6) 2019, 02:30PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490382 BD INSYTE¿ AUTOG¿ BC YEL 24GA X 0.75IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 30382903825128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other