BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7166163 · Received January 4, 2018

    Report

    Report Number
    1710034-2017-00507
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    December 12, 2017
    Report Date
    February 16, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814238
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: DHR REVIEW WAS CONDUCTED WITH THE FOLLOWING RESULTS DISCLOSED: THIS LOT (7212764) WAS BUILT ON (B)(4) ON 08AUG2017 THROUGH 11AUG2017 AND PACKAGED ON (B)(4). PER REVIEW IT WAS NOTED THAT THERE WERE 2 NON RELATED QNS INITIATED FOR THIS LOT AND NO RELATED REJECTED FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT OF THE CATHETERS FOR THE DEFECT NOTED IN THE PIR. ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. IN PROCESS SAMPLES FOR FOREIGN/NON FOREIGN MATERIAL, PARTICULATE LOOSE OR EMBEDDED WERE CONDUCTED AT VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE DISCLOSED. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. CONCLUSION: CONFIRMATION OF THE DEFECT STATED IN THE PIR COULD NOT BE IDENTIFIED OR CONFIRMED AND CAUSE COULD NOT BE DETERMINED, AS THE UNIT DESCRIBED IN THE PRODUCT INCIDENT REPORT WAS NOT PROVIDED FOR EVALUATION AND TESTING. THEREFORE, THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT STATED IN THE PIR. THIS INCIDENT IS INDETERMINATE. AS A ROOT CAUSE COULD NOT BE ESTABLISHED. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿BLACK SPECS¿ WERE FOUND IN A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER BY A NURSE PRIOR TO USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10448 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7212764 30382903814238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other