BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORIES FOR SPACE PUMPS

    MDR report key: 2900202 · Received November 19, 2012

    Report

    Report Number
    9610825-2012-00239
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Report Date
    November 16, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K083689
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B BRAUN (B)(4) (THE MFR). (B)(4). A HISTORICAL REVIEW OF THE CUSTOMER COMPLAINT DATABASE REVEALED NO ADVERSE TRENDS IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR ITEM #8713112C. IN A F/U WITH THE FACILITY, THE REPORTER CONFIRMED THERE WAS NO INCIDENT OF PT OR STAFF INJURY. THE REPORTER STATED THAT THE FACILITY WANTS TO DO A FULL INVESTIGATION INTO THE INCIDENT BEFORE THE CORD WILL BE RELEASED FOR EVAL. MULTIPLE ATTEMPTS TO CONTACT THE FACILITY TO OBTAIN ADD'L INFO AND THE SAMPLE HAVE NOT BEEN SUCCESSFUL. WITHOUT THE SAMPLE INVOLVED IN THE REPORTED INCIDENT, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSION CAN BE DRAWN. IF THE SAMPLE IS RETURNED AND/OR ADD'L PERTINENT INFO IS RECEIVED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CUSTOMER COMPLAINT REPORTED FOR A CORD THAT CAUGHT ON FIRE. INCIDENT DATE: UNK AT THIS TIME. INJURIES UNK AT THIS TIME. ADD'L INFO RECEIVED FROM THE FACILITY ON (B)(6) 2012 - THERE IS NO INCIDENT OF PT OR STAFF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESSORIES FOR SPACE PUMPS US POWER CORD INCL. EXTENSION FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other