BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGPN,270X10,HMPMPC,-,LFR-CS,10

    MDR report key: 6104175 · Received November 15, 2016

    Report

    Report Number
    2026095-2016-00198
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Report Date
    December 13, 2016
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    PK052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4) HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE (B)(4) COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 1

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED NINETEEN DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE ELEVENTH OF NINETEEN REPORTS. REFER TO 2026095-2016-00188 FOR THE FIRST PATIENT. REFER TO 2026095-2016-00189 FOR THE SECOND PATIENT. REFER TO 2026095-2016-00190 FOR THE THIRD PATIENT. REFER TO 2026095-2016-00191 FOR THE FOURTH PATIENT. REFER TO 2026095-2016-00192 FOR THE FIFTH PATIENT. REFER TO 2026095-2016-00193 FOR THE SIXTH PATIENT. REFER TO 2026095-2016-00194 FOR THE SEVENTH PATIENT. REFER TO 2026095-2016-00195 FOR THE EIGHTH PATIENT. REFER TO 2026095-2016-00196 FOR THE NINTH PATIENT. REFER TO 2026095-2016-00197 FOR THE TENTH PATIENT. REFER TO 2026095-2016-00199 FOR THE TWELFTH PATIENT. REFER TO 2026095-2016-00200 FOR THE THIRTEENTH PATIENT. REFER TO 2026095-2016-00201 FOR THE FOURTEENTH PATIENT. REFER TO 2026095-2016-00202 FOR THE FIFTEENTH PATIENT. REFER TO 2026095-2016-00203 FOR THE SIXTEENTH PATIENT. REFER TO 2026095-2016-00204 FOR THE SEVENTEENTH PATIENT. REFER TO 2026095-2016-00205 FOR THE EIGHTEENTH PATIENT. REFER TO 2026095-2016-00206 FOR THE NINETEENTH PATIENT. FILL VOLUME: 150 ML. FLOW RATE: 10 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: NOT APPLICABLE. IT WAS REPORTED THAT THERE WAS AN INCIDENT OF FAST FLOW ASSOCIATED WITH THE USE OF THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED ON 17NOV2016 STATED THAT A TOTAL OF ONLY 2 DEVICES FOR LOT # 0202119666 WERE IMPACTED. REFER TO MDR # 2026095-2016-00155 FOR DEVICE #1, LOT # 0202119666. REFER TO MDR # 2026095-2016-00198 FOR DEVICE #2, LOT # 0202119666.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755652 SURGPN,270X10,HMPMPC,-,LFR-CS,10 ELASTOMERIC LFR MEB HALYARD - IRVINE C270100-10 0202119666

    Patients

    Seq Age Sex Outcome Treatment
    1 FORTUN 3G