BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7527666 · Received May 18, 2018

    Report

    Report Number
    1710034-2018-00232
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    April 27, 2018
    Report Date
    July 23, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW: NO. REASON: ALTHOUGH THE REVIEW OF THE DHRS REVIEW ARE REQUIRED FOR MDR¿S PER MS-QS-083, A REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. THE PEURA (END USER RISK ANALYSIS): YES REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: RM5835 REV 12 VERSION J WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT CURRENT RISK IS ACCEPTABLE. OCCURRENCE AND SEVERITY RANKINGS HAVE NOT CHANGED. VISUAL ANALYSIS OBSERVATIONS AND TESTING: RECEIVED ONE UNUSED IAG/BC 22GA UNIT IN FROM THE LOT NUMBER 6112795. THE UNIT CONSISTED OF THE CATHETER/ADAPTER ASSEMBLY, NEEDLE/SAFETY BARREL ASSEMBLY AND THE NEEDLE COVER. VISUAL/MICROSCOPIC EXAMINATION: OBSERVED BLACK FM ON THE CATHETER TUBING NEAR THE TIP. THE FM MEASURED APPROXIMATELY .20 SQUARE MILLIMETERS. INVESTIGATION CONCLUSION: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: MANUFACTURING COMMENT: 5S CLEANING IS PERFORMED BY EACH SHIFT TO MINIMIZE THE POTENTIAL FOR INTRODUCING FOREIGN MATTER TO THE PRODUCT. POTENTIAL SOURCES OF FM INCLUDE ANY VIOLATIONS OF THE GMPS INCLUDING QS3-0035, WHICH DEFINES THE BD GOWNING POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS FOUND WITH FOREIGN MATTER AS ¿BLACK FM WAS ON THE CATHETER."THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. NO LOT # PROVIDED. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS FOUND WITH FOREIGN MATTER AS ¿BLACK FM WAS ON THE CATHETER."THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367961 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other