BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6994410 · Received November 1, 2017

    Report

    Report Number
    1710034-2017-00312
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    August 15, 2017
    Report Date
    November 12, 2017
    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
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CORRECTIVE ACTION STATEMENT IS APPROVED/AUTHORIZED AND FINAL REVIEW OF THE COMPLAINT WILL BE CONDUCTED BY DESIGNATED COMPLAINT HANDLING UNIT. EVENT DESCRIPTION: THE CATHETER HAS SAFETY PROBLEMS IN THE REAR CAMERA. WHEN THE FIXATIVE IS PUT INTO THE VEIN, WHEN UNSCREWED IT IS COMPLETELY SEPARATED FROM THE CATHETER GIVING FREE WAY TO THE BLOOD OUTLET CAUSING SPILLS ON THE NURSE AND IN THE ROOM. IN ADDITION, THE CATHETER HAS A LOT OF RIGIDITY AND THIS TENDS TO DAMAGE THE PATIENT¿S VEIN CAUSING IT TO BE PUNCTURED SEVERAL TIMES. LOT ANALYSIS: DEVICE/BATCH HISTORY RECORD REVIEW: YES. FINDINGS: AS THIS COMPLAINT WAS A MDR, DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBER: 6230808 ¿ THE LOT NUMBER WAS BUILT ON AFA LINE 4, FROM SEPTEMBER 8, 2016 THRU SEPTEMBER 9, 2016. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. OBSERVATIONS AND TESTING: OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: UNKNOWN; UNITS WERE NOT RECEIVED FOR OBSERVATION AND TESTING. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT INVESTIGATION CONCLUSION: CONCLUSIONS: THE DEFECTS OF LEAKAGE, CATHETER DIFFICULT TO REMOVE, BLOOD EXCESS/SPLASH/SPILL/EXPOSURE OR SEPARATION CATHETER FROM ADAPTER; AS REPORTED CODES COULD NOT BE IDENTIFIED OR CONFIRMED AND CAUSE COULD NOT BE DETERMINED, AS THE UNITS DESCRIBED IN THE PRODUCT INCIDENT REPORT WERE NOT RETURNED FOR EVALUATION AND TESTING. THEREFORE, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT STATED IN THE DESCRIPTION OF THE COMPLAINT. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? NO; UNABLE TO CONFIRM THE CUSTOMER¿S EXPERIENCE BECAUSE UNITS WERE NOT RETURNED FOR EVALUATION AND TESTING. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO; UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE BECAUSE UNITS WERE NOT RETURNED FOR EVALUATION AND TESTING. RATIONALE: ROOT CAUSE COULD NOT BE DETERMINED. 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. OTHER ACTION TAKEN: PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS AND/OR PROCESS CONTROL TECHNICIANS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 THE 24 G X 0.56 IN. BD INSYTE-N AUTOGUARD SHIELDED IV CATHETER WAS DIFFICULT TO THREAD, AND LEAKS DURING USE. NO REPORTS OR SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774533 24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6230807

    Patients

    Seq Age Sex Outcome Treatment
    1 Other