BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMLINE LID

    MDR report key: 7928166 · Received October 2, 2018

    Report

    Report Number
    9610612-2018-00457
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    September 11, 2018
    Report Date
    May 2, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    KCT
    PMA / PMN Number
    K073168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2014018. INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT #. INVESTIGATION: THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS, THEREFORE AN ACCURATE ANALYSIS IS NOT POSSIBLE. ISSUE DESCRIPTION - HAVE BEEN GETTING WET SETS DUE TO LIDS (PRIME LINE). OUR ANALYSIS - COMPLAINT FOR PRODUCT JP002 CHECKED WITH TRANSACTIONS FOR PERIOD (B)(6) 2017-(B)(6) 2018 AND NO FURTHER COMPLAINTS ABOUT THIS ERROR DESCRIBED EXIST. WITHOUT FURTHER INFORMATION, THE CAUSE IS MOST LIKELY DUE TO IMPROPER HANDLING DURING REPROCESSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SETS STERILIZED USING PRIMELINE LIDS HAVE RESULTED IN WET SETS. THERE WAS NO PATIENT INJURY REPORTED, HOWEVER, THERE WAS A SURGICAL DELAY OF 30 TO 40 MINUTES. IT WAS NOT REPORTED IF THE PATIENT WAS UNDER ANESTHESIA DURING THE DELAY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION AND CLARIFICATION WAS NOT PROVIDED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN FOLLOW-UP INFORMATION. THE ORIGINAL COMPLAINT FORM STATED THAT THE INCIDENT DID NOT OCCUR IN SURGERY BUT IN CENTRAL STERILE PROCESSING (CSP); IT CONTRIBUTED TO A DELAY PRIOR TO THE START OF A SURGERY. THE WETNESS WAS FOUND DIRECTLY BEFORE AN OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768039 PRIMLINE LID STERILIZATION CONTAINER LID KCT AESCULAP AG JP002

    Patients

    Seq Age Sex Outcome Treatment
    1