BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1.00 IN. BD INSYTE¿ PERIPHERAL VENOUS CATHETER

    MDR report key: 6761062 · Received August 2, 2017

    Report

    Report Number
    8041187-2017-00062
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    July 1, 2017
    Report Date
    September 15, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: 20 REPRESENTATIVE SAMPLES IN CLOSED PACKAGING WERE RETURNED FOR INVESTIGATION. REPRESENTATIVE SAMPLES. THE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION. CANNULA PIERCED THROUGH CATHETER WAS OBSERVED ON SAMPLE #2. NO ABNORMALITIES WAS OBSERVED ON THE REST OF THE RETURNED SAMPLES. CANNULA PIERCED THROUGH CATHETER OF SAMPLE #2. THE NONCONFORMANCE SAMPLE WAS CHALLENGED AT THE AUTOMATED VISION INSPECTION SYSTEM. THE SYSTEM WAS ABLE TO REJECT THE NONCONFORMANCE AND THE SAMPLE WAS SENT INTO THE REJECT BIN. THE REPRESENTATIVE SAMPLES WERE SUBJECTED TO CANNULA AND CATHETER PENETRATION TEST. THE RESULTS SHOWED THAT ALL RETURNED SAMPLES HAVE PASSED THE PENETRATION TEST. CANNULA PIERCED THROUGH CATHETER WAS OBSERVED ON SAMPLE #2. NO ABNORMALITIES WAS OBSERVED ON THE REST OF THE RETURNED SAMPLES. THE NONCONFORMANCE COULD HAVE OCCURRED DURING ASSEMBLY OF CATHETER AND CANNULA. HOWEVER, THERE IS AN AUTOMATED VISION INSPECTION MACHINE, WHICH CAN DETECT AND REJECT PRODUCT WITH CANNULA PIERCED THROUGH CATHETER IN THE ASSEMBLY PROCESS. HENCE, THE ROOT CAUSE OF THE NONCONFORMANCE COULD NOT BE DETERMINED. THE TREND OF THIS NONCONFORMANCE WILL BE MONITORED. THERE IS AN AUTOMATED VISION INSPECTION MACHINE, WHICH CAN DETECT AND REJECT PRODUCT WITH CANNULA PIERCED THROUGH CATHETER IN THE ASSEMBLY PROCESS. DHR REVIEW: DEVICE HISTORY RECORD OF PACKAGED NEEDLE BATCH 7038127, CATALOGUE NUMBER 381223 AND ITS ASSEMBLED NEEDLE BATCHES 6354468 AND 7120336. PART NUMBER YF01223SGT WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCE DURING THE PRODUCTION OF THIS BATCH.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA WAS BROKEN AND SPLIT ON A 22 G X 1.00 IN. BD INSYTE¿ PERIPHERAL VENOUS CATHETER DURING USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540032 22 G X 1.00 IN. BD INSYTE¿ PERIPHERAL VENOUS CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7038127

    Patients

    Seq Age Sex Outcome Treatment
    1 Other