BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8366867 · Received February 25, 2019

    Report

    Report Number
    9610048-2019-00122
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    February 6, 2019
    Report Date
    August 31, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D3. MEDICAL DEVICE MANUFACTURER:BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SANDY, UT. G1. MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SANDY, UT. THE PRODUCT IS MADE IN SANDY, UT AND PACKAGED IN JUIZ DE FORA, BR. THIS REPORT ERRANTLY REPORTED THE MANUFACTURER AS JUIZ DE FORA, BR.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR:LOT WAS BUILT ON AFA LINE 4 ON (B)(6)2018 THROUGH (B)(6)2018 FOR THE QUANTITY OF (B)(4) EA AND BULK PACKAGED. ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SETUP AND IN-PROCESS SAMPLING PLANS AND ALL PASSED PER SPECIFICATIONS. THERE WERE NO INDICATIONS OF THE DEFECT AS IT WAS NOTED THAT THERE WERE REJECT FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE CATHETER PRODUCT. ALTHOUGH UNITS WERE NOT RETURNED FOR INVESTIGATION, PHOTOS WERE PROVIDED FOR OBSERVATION OF THIS INCIDENT. THE PHOTOS REVEALED A MISCELLANEOUS UNIT TO BE OUT OF THE PACKAGING WHICH CONSISTED OF A NEEDLE/HUB ASSEMBLY WITH TRACES OF THICK MEDIA PRESENT. VISUAL/MICROSCOPIC: THE PHOTOS REVEALED THE UNIT SHOWN IN BOTH PHOTOS WAS NOT OF BD PRODUCT. RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE CONFIRMATION OF NEEDLE RETRACTION FAILURE, AS STATED IN THE PIR, WAS NOT IDENTIFIED OR CONFIRMED BASED ON THE OBSERVATION OF THE PHOTOS PROVIDED FOR THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE ESTABLISHED. THE PHOTOS PROVIDED FOR THIS INCIDENT REVEALED EVIDENCE THAT THE UNIT SHOWN WAS NOT BD PRODUCT; THEREFORE THESE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER IT WAS DIFFICULT TO ACTIVATE THE SAFETY MECHANISM, BECAUSE IT LOCKED AND THE NEEDLE DID NOT RETRACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER IT WAS DIFFICULT TO ACTIVATE THE SAFETY MECHANISM, BECAUSE IT LOCKED AND THE NEEDLE DID NOT RETRACT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER IT WAS DIFFICULT TO ACTIVATE THE SAFETY MECHANISM, BECAUSE IT LOCKED AND THE NEEDLE DID NOT RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161643 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8242849 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other