BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9936025 · Received April 8, 2020

    Report

    Report Number
    1710034-2020-00249
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 13, 2020
    Report Date
    May 26, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED TWO TOP WEB (LABELS) FROM REFERENCE NUMBER 381923; ONE FROM LOT NUMBER 9193567 AND ONE FROM LOT NUMBER 9163687. ONE USED UNIT WAS ALSO RECEIVED WHICH CONSISTS OF THE CATHETER / ADAPTOR ASSEMBLY THAT HAS THICK TRACES OF DRIED MEDIA PRESENT. IN ADDITION, FOUR PHOTOGRAPHS WERE SUBMITTED WHICH REVEALED SIMILARITIES TO THAT OF THE RETURNED UNIT. UPON VISUAL INSPECTION OF THE RETURNED UNIT, IT IS OBSERVED THAT THERE IS DAMAGE TO THE THREADS AT THE OUTSIDE OF THE LUER. THIS DAMAGE TO THE OUTER THREADS OF THE LUER WOULD PREVENT A CONNECTION TO BE ACHIEVED AS DESCRIBED IN YOUR REPORT. THE DAMAGE IS ONLY ON ONE SIDE OF THE ADAPTER. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING EQUIPMENT RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO AN EQUIPMENT MISALIGNMENT. ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED, WE WERE UNABLE TO IDENTIFY WHICH LOT NUMBER THE USED UNIT BELONGED TO. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS DEFECTIVE. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CATHETER PLACEMENT, HCP TRIED TO CONNECT EX-CABLE HOWEVER CATHETER ADAPTER WAS DEFECT AND S/HE COULDN'T CONNECT IT. REPLACED BY NEW PRODUCT AND PLACED THE CATHETER AGAIN. THERE WAS NO PROBLEM.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9193567. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2019-07-12. MEDICAL DEVICE LOT #: 9163687. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2019-06-12. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS DEFECTIVE. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CATHETER PLACEMENT, HCP TRIED TO CONNECT EX-CABLE HOWEVER CATHETER ADAPTER WAS DEFECT AND S/HE COULDN'T CONNECT IT. REPLACED BY NEW PRODUCT AND PLACED THE CATHETER AGAIN. THERE WAS NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400266 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other