BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I.V. CATHETER EXT SET/LUER LOCK ADAPTERS

    MDR report key: 1770663 · Received July 27, 2010

    Report

    Report Number
    6000001-2010-01953
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K811078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF BROKEN WAS CONFIRMED. DURING VISUAL INSPECTION, IT WAS OBSERVED THAT THERE WAS A MALE LUER LOCK ADAPTER PART MISSING. DIMENSIONAL INSPECTION WAS PERFORMED ON THE TUBING AND THE TUBING OUTER DIAMETER WAS OUT OF TOLERANCE. THE UNIT WAS PRESSURE TESTED AT 8PSI, BUT NO LEAK WAS OBSERVED. THE MOST PROBABLE ROOT CAUSE FOR THE MISSING MALE LUER LOCK COULD BE RELATED TO THE SMALLER OUTER DIAMETER OF THE TUBING. IF THE TUBING OUTER DIAMETER IS SMALL IT IS POSSIBLE THAT THE TUBING AND THE MALE LUER LOCK IS NOT HAVE A GOOD BONDING. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN IV (INTRAVENOUS) CATHETER EXTENSION SET IN WHICH THE T-CONNECTOR WAS FOUND BROKEN OFF OF THE PERIPHERAL IV. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE

    Description of Event or Problem · 1

    THE MALFUNCTION OCCURRED BEFORE USAGE, SO NO PATIENT WAS INVOLVED.

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "FLUCTUATING BCVA" (VISION, IMPAIRED). PRODUCT PROBLEM(S): "VERTICAL CRACK" (CRACK [IOL (INTRAOCULAR LENS) IMPLANT]): "THINK SHEET OF MATERIAL ON THE ANTERIOR SURFACE" (NO CODE AVAILABLE [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE NOTED WHAT APPEARED TO BE A VERTICAL "CRACK" OF APPROXIMATELY 3-4MM IN LENGTH ON THE IOL AND SEEMS TO BE RIGHT IN THE VISUAL AXIS. ALSO, HE NOTED THAT, BEGINNING AT THE CRACK AND RUNNING TEMPORALLY PAST THE EDGE OF THE PUPIL, THERE APPEARS TO BE A THIN SHEET OF MATERIAL ON THE ANTERIOR SURFACE OF THE IOL. HE ALSO REPORTED THAT THERE WERE NO PROBLEMS INSERTING OR POSITIONING THE IOL DURING THE SURGERY. HE ALSO STATED THAT AT THE LAST POSTOPERATIVE VISIT, THE PT'S BCVA FLUCTUATES, BUT WAS NEVER BETTER THAN 20/60. THE SURGEON CONTINUES TO WORK WITH THE PT FOR SOLUTIONS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I.V. CATHETER EXT SET/LUER LOCK ADAPTERS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1