BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN CVC KIT: 3-LUMEN 7 FR X 6IN

    MDR report key: 1842052 · Received August 27, 2010

    Report

    Report Number
    1036844-2010-00266
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE SURGICAL INTENSIVE CARE UNIT (SICU) THEY PREPARED TO INSERT A TRIPLE LUMEN CATHETER. THE ARROW RAULERSON SYRINGE (ARS) WAS REMOVED FROM THE PACKAGE AND THE PHYSICIAN NOTICED THE TIP OF THE NEEDLE WAS DAMAGED/SERRATED. THE ARS WAS DISCARDED AND ANOTHER KIT WAS USED WITH SUCCESS. THERE WAS NO PATIENT DEATH OR INJURY. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADD'L INFO RECEIVED ON (B)(4) 2010, FROM THE SALES REP STATED THE ARS IS NOT CONTAINED IN THIS LOT NUMBER FOR THIS PRODUCT. IT WAS THE 18 GAUGE INTRODUCER NEEDLE THAT THEY EXPERIENCED DIFFICULTY WITH. A CHANGE IS BEING MADE TO THIS KIT TO INCLUDE THE ARS IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN CVC KIT: 3-LUMEN 7 FR X 6IN ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK