BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE SET FOR SUCTION SINGLE-USE

    MDR report key: 9394564 · Received December 2, 2019

    Report

    Report Number
    3002914049-2019-00017
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Report Date
    April 30, 2020
    Manufacturer
    W.O.M. WORLD OF MEDICINE GMBH
    Product Code
    HIG
    UDI-DI
    04056702002190
    PMA / PMN Number
    K112642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WOM FILED THE INITIAL REPORT ON 29-NOV-2019 (MFR NO. 3002914049-2019-00017). WOM ATTEMPTED TO OBTAIN INFORMATION AND TUBE SETS FROM THE COMPLAINANT, BUT NEITEHR ADDITIONAL INFORMATION NOR THE DEVICES WERE PROVIDED. WOM MONITORED CLOSELY OVER THE THREE MONTHS WHETHER THERE ARE ANY OTHER SIMILAR COMPLAINTS. NONE SIMILAR COMPLAINTS WERE FILED WITH WOM. WOM CLOSED THE FILES ON THIS EVENT.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "(B)(6) REPORTS SHE HAS AQUILEX TUBING OF LOTS K18G175 AND K18K265 THAT APPEAR TO HAVE TINY PIN HOLES IN THE PACKAGE AND SOME SORT OF TINY PARTICLES RUBBING FROM INSIDE CREATING THESE HOLES."

    Additional Manufacturer Narrative · 1

    LOT: K18G175 MANUFACTURING DATE: 2018-07-01 EXPIRATION DATE: 2021-07-01. LOT: K18K265 MANUFACTURING DATE: 2018-09-01 EXPIRATION DATE: 2021-09-01. THE TUBE SET FOR SUCTION SINGLE-USE AQL-111 IS PACKAGED IN A DOUBLE BLISTER. THE COMPLAINT ONLY STATES THAT IT "APPEARS" AS IF THERE ARE TINY PIN HOLES IN THE PACKAGING. THIS ERROR DESCRIPTION BASED ON "OPTICAL PIN IMPRESSIONS" DOES NOT CONFORM AN ACTUALLY PIERCED STERILE BARRIER. TO PIERCE THROUGH ONE BLISTER A CERTAIN AMOUNT OF FORCE IS REQUIRED AND SUCH DAMAGE WOULD BE VISIBLE. THEREFORE, CONSIDERING THAT EVEN IN THE UNLIKELY EVENT OF A PERFORATION, NOT BOTH BLISTERS ARE NECESSARILY PIERCED. CORRESPONDING TRANSPORTATION TESTS HAD BEEN CARRIED OUT AND PASSED DURING DEVELOPMENT. THE ROOT CAUSE CANNOT BE DETERMINED YET, AS WE DID NOT RECEIVE THE TUBE SETS FOR INVESTIGATION. WE COULD ALSO NOT OBTAIN FURTHER INFORMATION FROM THE COMPLAINANT. HOWEVER, THE MANUFACTURING SITE INFUS MEDICAL (B)(4) CO., LTD. CHECKED THE RETAIN SAMPLES (3 UNITS EACH LOT) AND COULD NOT DETERMINE ANY DAMAGE IN THE INNER OR OUTER BLISTER NOR TO THE STERILE BARRIER. ALSO THE DHRS DO NOT SHOW ANY ABNORMALI-TIES OR DEVIATIONS. THE AQL-111 BELONGS TO THE GROUP OF INTERNALLY DESIGNATED ST282 TUBE SETS. THIS IS THE FIRST COMPLAINT OF THIS KIND OF A TOTAL OF (B)(4) DELIVERED ST282 TUBE SETS UNTIL TODAY. IT CANNOT BE EXCLUDED OR CON-FIRMED THAT A MALFUNCTION EXISTS IN THIS CASE, THEREFORE AN INITIAL REPORT WILL BE FILED. WOM WILL CONTINUE TO ATTEMPT TO OBTAIN INFORMATION AND TUBE SETS FROM THE COMPLAINANT AND WILL MONITOR VERY CLOSELY OVER THE NEXT THREE MONTHS WHETHER THERE ARE ANY OTHER SIMILAR COMPLAINTS. WE ACKNOWLEDGE THAT WE ARE FILING THIS REPORT PAST THE 30-DAYS FRAME. THE INDIVIDUAL WHO MADE THE INITIAL ASSESSMENT FOR REPORTABILITY ERRED AND THIS WAS CAUGHT UPON SECONDARY REVIEW.

    Description of Event or Problem · 1

    WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "(B)(6) REPORTS SHE HAS AQUILEX TUBING OF LOTS K18G175 AND K18K265 THAT APPEAR TO HAVE TINY PIN HOLES IN THE PACKAGE AND SOME SORT OF TINY PARTICLES RUBBING FROM INSIDE CREATING THESE HOLES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193731 TUBE SET FOR SUCTION SINGLE-USE HYSTEROSCOPY PUMP AND SCALE HIG W.O.M. WORLD OF MEDICINE GMBH AQL-111 K18G175 , K18K265 04056702002190

    Patients

    Seq Age Sex Outcome Treatment
    1