BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7861783 · Received September 10, 2018

    Report

    Report Number
    1710034-2018-00619
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Date of Event
    August 13, 2018
    Report Date
    November 21, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: LOT #8100785 - REVIEW OF THE DHR¿S REVEALED THAT ALL CHALLENGE, SET-UP AND IN-PROCESS SAMPLES WERE PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. NO QUALITY NOTIFICATIONS WERE INITIATED DURING PRODUCTION. RECEIVED 1 IAG 22GA UNIT WITHIN A SEALED PACKAGE FROM LOT 8100785. ALL COMPONENTS WERE PRESENT AND INTACT. VISUAL EXAMINATION: NO PHYSICAL-MECHANICAL DAMAGE DETECTED ON ANY OF THE COMPONENTS OF THE RECEIVED UNIT. THE CATHETER AND THE NEEDLE TIP WERE ACCEPTABLE PER SPECIFICATIONS. THE PENETRATION AND DRAG TEST WAS PERFORMED AND WITHIN SPECIFICATIONS WITH A RESULT OF: 19.2 GF (CATHETER PENETRATION), 23.1 GF (NEEDLE PENETRATION) AND 1.3 GF (CATHETER DRAG). THE FLASHBACK TEST WAS PERFORMED BY INSERTING THE UNIT INTO A LAB PROVIDED ARTIFICIAL VEIN: LIQUID WAS OBSERVED ON THE FLASHBACK CHAMBER AND ON THE NEEDLE NOTCH (WHEN TESTED BY ITSELF). THE WATER-LEAK TEST WAS PERFORMED ON THE CATHETER ADAPTER ASSEMBLY AND NO LEAKAGE WAS OBSERVED ON ANY OF IT COMPONENTS. CONCLUSION(S): NO PHYSICAL-MECHANICAL DAMAGE WAS OBSERVED ON ANY OF THE COMPONENTS OF THE RECEIVED UNIT AND NO MANUFACTURING RELATED ISSUES THAT WOULD TRIGGER THE FAILURE EXPERIENCED BY THE CUSTOMER WAS FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    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 WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703934 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8100785 30382903815235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other