BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 3271355 · Received July 25, 2013

    Report

    Report Number
    9610825-2013-00091
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K982805
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MEDICAL INC IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4) (THE MFR) AND (B)(4) (THE IMP). (B)(4). ONE USED SAMPLE (NEEDLE AND CATHETER HUB) TOGETHER WITH THE PACKAGING REFERRING TO 2A12258302/4251652-02 WAS RETURNED FOR EVAL. THE SAMPLE AND ALL AVAILABLE INFORMATION WAS FORWARDED TO THE ACTUAL MFR, B. BRAUN (B)(4), FOR FURTHER INVESTIGATION. THEIR REPORT STATED THAT THE RETURNED SAMPLE (NEEDLE) WAS VISUALLY CHECKED AND FOUND THAT THE SAFETY CLIP WAS STUCK HALFWAY OF THE NEEDLE (APPROX 15MM FROM THE TIP OF THE CATHETER). THE CLIP DIMENSIONS AND THE CATHETER DIMENSIONS WERE MEASURED AND FOUND TO BE IN SPECIFICATION. THE RETURNED CATHETER WAS THEN ASSEMBLED ONTO THE NEEDLE OF THE RETURNED SAMPLE TO CHECK IF THE SAFETY CLIP WOULD ENGAGE. THE CATHETER WAS PULLED OUT UNTIL THE END OF THE CANNULA TIP AND UPON REMOVAL OF THE CATHETER THE SAFETY CLIP ENGAGED ONTO THE CANNULA TIP. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS PERFORMED BY B. BRAUN (B)(4) FOR THE AFOREMENTIONED LOT AND THERE WERE NO ABNORMALITIES OR NON-CONFORMANCES NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. NO ADVERSE QUALITY TRENDS WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR FG ITEM #4251652-02. THERE WERE NO OTHER COMPLAINTS OF THIS NATURE AGAINST FG LOT #2A12258302. THE REPORTED DEFECT COULD NOT BE DUPLICATED AND NO SPECIFIC CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347527 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1