BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER EXT SET-JAPAN ONLYMICOBORE 2 ADAPTER Y-JUNCTION

    MDR report key: 1961836 · Received January 14, 2011

    Report

    Report Number
    6000001-2011-00276
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. A VISUAL EXAMINATION OF THE SAMPLE DID NOT SHOW ANY DEFICIENCIES. HOWEVER WHEN WATER WAS INJECTED INTO THE SET WITH A SYRINGE, THERE WAS A NO FLOW DETECTED THAT OCCURRED BETWEEN THE TUBING AND THE LUER LOCK DUE TO SOLVENT BLOCKAGE. THE ROOT CAUSE OF THE CONDITION WAS DETERMINED TO BE MANUFACTURING OPERATOR ERROR. AS A CORRECTIVE ACTION, MANUFACTURING PERSONNEL WERE RETRAINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS AVAILABLE FOR EVALUATION; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED. ONCE THE SAMPLE IS RECEIVED AND EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, AN MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A CATHETER EXTENSION SET THAT HAD RESISTANCE WHEN TRYING TO INJECT SALINE INTO THE SET. THE REPORTED CONDITION OCCURRED DURING PATIENT-USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INVOLVED. NO ADDTIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER EXT SET-JAPAN ONLYMICOBORE 2 ADAPTER Y-JUNCTION SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR10C25033

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE