BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ IV CATHETER

    MDR report key: 8701205 · Received June 14, 2019

    Report

    Report Number
    8041187-2019-00455
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 14, 2019
    Report Date
    October 2, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    30382903812128
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. THE NEEDLE WAS OBSERVED TO BE BENT NEAR THE TIP OF THE CATHETER. THE INVESTIGATION WAS ABLE TO VERIFY WHAT THE CUSTOMER HAD EXPERIENCED AS BENT NEEDLE WAS OBSERVED ON THE RETURNED SAMPLES. PROBABLE ROOT CAUSES: POTENTIAL CANNULA TO HUB ANGULARITY HITTING NEEDLE COVER CAUSING THE CANNULA BEND. THIS COULD BE RESULT OF THE MOLDING ISSUE WHICH MAY HAVE CAUSE THE CANNULA TO HUB ANGULARITY. HIGH MACHINE SCRAP AND STOPPAGES OBSERVED DURING THIS LOT. MOLDING IMPROVED THE CANNULA SEAT TO REDUCE THE ANGULARITY OF THE CANNULA AND REDUCING THE PRODUCTION SCRAP. DEVICE HISTORY RECORD OF PACKAGED NEEDLE (PN) BATCH 8234041 CATALOGUE NUMBER 381212 AND ITS ASSEMBLED NEEDLE (AN) BATCH 8239307 AND PART NUMBER YF01212SGT WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CANNULA IS SPLITTING WITH A BD INSYTE¿ IV CATHETER. THIS OCCURRED ON 3 SEPARATE OCCASIONS DURING USE BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OVER THE LAST FEW WEEKS THERE HAS BEEN AN INCREASING NUMBER OF REPORTS RELATED TO DIFFICULT CANNULATIONS. THIS HAS BEEN REPORTED BY EXPERIENCED CANNULATION NURSES AND MEDICAL OFFICERS. UPON REVIEW IT APPEARS THAT THE INTRODUCER MAY SPLIT THE PLASTIC NEEDLE (CANNULA) THUS MAKING THE PROCEDURE UNSUCCESSFUL.

    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 CANNULA IS SPLITTING WITH A BD INSYTE¿ IV CATHETER. THIS OCCURRED ON 3 SEPARATE OCCASIONS DURING USE BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OVER THE LAST FEW WEEKS THERE HAS BEEN AN INCREASING NUMBER OF REPORTS RELATED TO DIFFICULT CANNULATIONS. THIS HAS BEEN REPORTED BY EXPERIENCED CANNULATION NURSES AND MEDICAL OFFICERS. UPON REVIEW IT APPEARS THAT THE INTRODUCER MAY SPLIT THE PLASTIC NEEDLE (CANNULA) THUS MAKING THE PROCEDURE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495640 BD INSYTE¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8234041 30382903812128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other