BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ IV CATHETER

    MDR report key: 9844759 · Received March 17, 2020

    Report

    Report Number
    8041187-2020-00153
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    February 25, 2020
    Report Date
    April 6, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    30382903812449
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION, A TRANSPARENT LIKE FOREIGN MATTER WAS OBSERVED TO BE ON THE CATHETER; THEREFORE, THE INCIDENT COULD BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. SINCE A SAMPLE WAS NOT RECEIVED NO FURTHER INVESTIGATION COULD BE CONDUCTED; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT WILL BE REOPENED IF A SAMPLE IS RECEIVED. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN "EXTRA PIECE OF PLASTIC" WAS FOUND ON THE BD INSYTE¿ IV CATHETER BEFORE INSERTING IT INTO THE PATIENT, AND IT "CAME OFF WHEN TOUCHED". LOT#'S 8234059, 9014978, 8082178, AND 9054551 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, EACH WITH (B)(4) OCCURRENCES OF THE EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR DOCTORS NOTICED ON X2 CASES THAT AS HE WAS ABOUT TO INSERT A 18G JELCO THAT THERE WAS AN EXTRA PIECE OF PLASTIC ON THE OUTSIDE OF THE JELCO. THE PLASTIC CAME OFF WHEN TOUCHED. I THINK IT IS A HIGH RISK OF GOING UNNOTICED AND POTENTIALLY BEING INSERTED INTO PATIENT.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8234059. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2018-08-22. MEDICAL DEVICE LOT #: 9014978. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. DEVICE MANUFACTURE DATE: 2019-01-14. MEDICAL DEVICE LOT #: 9054551. MEDICAL DEVICE EXPIRATION DATE: 2024-02-28. DEVICE MANUFACTURE DATE: 2019-02-23. THE REPORTED LOT # [8082178] WAS NOT FOUND FOR THE REPORTED CATALOG # [381244]. 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 AN "EXTRA PIECE OF PLASTIC" WAS FOUND ON THE BD INSYTE¿ IV CATHETER BEFORE INSERTING IT INTO THE PATIENT, AND IT "CAME OFF WHEN TOUCHED". LOT#'S 8234059, 9014978, 8082178, AND 9054551 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, EACH WITH 2 OCCURRENCES OF THE EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR DOCTORS NOTICED ON X2 CASES THAT AS HE WAS ABOUT TO INSERT A 18G JELCO THAT THERE WAS AN EXTRA PIECE OF PLASTIC ON THE OUTSIDE OF THE JELCO. THE PLASTIC CAME OFF WHEN TOUCHED. I THINK IT IS A HIGH RISK OF GOING UNNOTICED AND POTENTIALLY BEING INSERTED INTO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309247 BD INSYTE¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 381244 SEE SECTION H.10. 30382903812449

    Patients

    Seq Age Sex Outcome Treatment
    1 Other