BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ N IV CATHETER

    MDR report key: 7303592 · Received February 28, 2018

    Report

    Report Number
    8041187-2018-00044
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Date of Event
    February 2, 2018
    Report Date
    April 3, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    K942045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: FOUR PHOTOS WERE RECEIVED FOR INVESTIGATION. INCORRECT NEEDLE LENGTH FROM THE PRINT ON TOP WEB WAS OBSERVED IN THE RETURNED PHOTOS. ONE ACTUAL SAMPLE WITHOUT FLOW PLUG IN OPENED PACKAGING WAS RETURNED FOR INVESTIGATION. ACTUAL SAMPLE. THE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION. INCORRECT NEEDLE LENGTH FROM THE PRINT ON TOP WEB WAS OBSERVED ON THE RETURNED SAMPLE. ADDITIONALLY, THE CANNULA OF THE RETURNED SAMPLE DOES NOT HAVE A NOTCH WHEN COMPARED TO THE CORRECT CATALOG PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7051294. INVESTIGATION CONCLUSION: THE INSYTE MANUFACTURING PROCESSES WERE REVIEWED TO IDENTIFY THE POSSIBLE ROOT CAUSE OF THE INCORRECT LENGTH COMPLAINT. ICAM: A PROBABLE ROOT CAUSE IN THE ICAM PROCESS COULD BE DUE TO THE CHANGEOVER AND CLEARANCE NOT DONE PROPERLY AND VERIFIED. HOWEVER, THERE IS A VISION SYSTEM INSTALLED IN THE ASSEMBLY LINE THAT IS ABLE TO DETECT THE INCORRECT PRODUCT. INSPECTORS WILL RETURN SAMPLES USED FOR VISUAL INSPECTION (NON-DESTRUCTIVE TESTING) BACK TO GOOD BIN. A FAILURE TO CHECK AND VERIFY THE ASSEMBLED NEEDLE (AN) SKU AND THE ASSEMBLY LINE MAY LEAD TO THE INCORRECT PRODUCT TO BE RETURNED INTO THE GOOD BIN. HOWEVER, THERE IS A VISION SYSTEM INSTALLED IN THE PACKAGING LINE TO DETECT AND REJECT AN PARTS WITH INCORRECT LENGTH. PACKAGING LINE 1: ONE PROBABLE ROOT CAUSE IN THE PACKAGING LINE 1 COULD BE A FAILURE TO CHECK AND VERIFY THE AN SKU IN BAGS BEFORE LOADING INTO THE PACKAGING LINE. HOWEVER, THERE IS A VISION SYSTEM INSTALLED IN THE PACKAGING LINE TO DETECT AND REJECT AN PARTS WITH INCORRECT LENGTH. ANOTHER PROBABLE ROOT CAUSE IN THE PACKAGING LINE 1 COULD BE DUE TO THE CHANGEOVER AND LINE CLEARANCE NOT DONE PROPERLY AND VERIFIED. HOWEVER, THE PRODUCTION HISTORY RECORDS SHOWED THAT THE PREVIOUS AN BATCH PACKED IN THE PACKAGING LINE 1 WAS DIFFERENT FROM THE RETURNED COMPLAINT SAMPLE RECEIVED AND HENCE, NOT THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE LENGTH ON A BD INSYTE¿ N IV CATHETER WAS DIFFERENT FROM THE LENGTH WRITTEN ON THE PACKAGE. THIS WAS OBSERVED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146059 BD INSYTE¿ N IV CATHETER INTRAVENOUS CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7051294

    Patients

    Seq Age Sex Outcome Treatment
    1 Other