BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MURANAKA SURGICAL MARKING PEN W;/RULER AND 6-UP LABELS, STERILE

    MDR report key: 12333208 · Received August 17, 2021

    Report

    Report Number
    1836161-2021-00034
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    May 17, 2021
    Report Date
    July 20, 2021
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    FZZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ASPEN SURGICAL PRODUCTS, INC. WOULD LIKE TO NOTIFY YOU OF OUR DECISION TO STOP REPORTING COMPLAINT RECORDS RELATED TO SEAL ISSUES FOR MARKING PEN PRODUCTS. ON SEPTEMBER 5TH, 2018, MFR REPORT NUMBER 1836161-2018-00092 WAS CREATED FOR SEAL ISSUES. THE COMPLAINT DOCUMENTED THAT THE CUSTOMER REJECTED PRODUCT DUE TO DISCOVERING THAT THE PACKAGING HAD BEEN COMPROMISED WITH THE PRODUCT IN THE FORMED SEAL. NO INJURY WAS REPORTED. REPORTED ISSUE WAS DISCOVERED BY THE DISTRIBUTOR PRIOR TO THE PRODUCT BEING USED. THE COMPLAINT WAS ASSESSED TO BE REPORTABLE AS A PRODUCT PROBLEM THAT COULD LEAD TO A SERIOUS INJURY IF IT WERE TO RECUR. THE MARKING PEN RISK ASSESSMENT DOCUMENTS THE SITUATION ASSOCIATED WITH SEAL ISSUES OR A BREACH IN THE STERILE BARRIER TO BE A CRITICAL SEVERITY. HOWEVER, UPON REVIEW OF THE COMPLAINT RECORD AND THE RISK ASSESSMENT PROBABILITY, PREVENTATIVE MEASURES ARE IN PLACE FOR THE USE OF THE PRODUCT ON THE EVENT THAT THE BARRIER OF THE PRODUCT BECOMES COMPROMISED. THIS INCLUDES COMMON PRACTICES BY MEDICAL PROFESSIONALS TO INSPECT THE PRODUCT PRIOR TO USE AND IDENTIFICATION OF THE FAILURE MODE ON THE PACKAGING. THE SYMBOL LOCATED ON THE LABELING OF THE PRODUCT, IDENTIFIES THIS FAILURE MODE WITH THE SYMBOL "DO NOT USE IF PACKAGE IS DAMAGED". THIS INDICATES THAT THE DEVICE SHOULD NOT BE USED IF THE PRODUCTS STERILE BARRIER SYSTEM OR ITS PACKAGING IS COMPROMISED. A REVIEW OF MDR DATA SHOWS THAT ASPEN SURGICAL PRODUCTS, INC. HAS FILED 37 REPORTS (LISTED BELOW) AS PRODUCT PROBLEMS FOR SEAL ISSUES OF THE MARKING PEN PRODUCTS IN THE PAST THREE YEARS SINCE THE DATE OF THE REPORT NUMBER 1836161-2018-00092. AS INDICATED THE COMPLAINT RECORDS, ALL REPORTED SEAL ISSUES WERE DISCOVERED PRIOR TO USE. NONE OF THESE COMPLAINTS WERE RELATED TO ANY INJURIES TO PATIENTS OR CAREGIVERS. BASED ON THE STANDARD MEDICAL PRACTICES, LABELING, AND NO SUBSEQUENT ALLEGATIONS OF INJURY IN THE PAST THREE YEARS RELATED TO SEAL ISSUES OF THE MARKING PEN PRODUCTS, ASPEN SURGICAL PRODUCTS, INC. WILL NO LONGER REPORT ON THESE OCCURRENCES TO THE FDA IN ACCORDANCE WITH SECTION 2.15 OF THE ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF¿ ISSUED ON NOVEMBER 8TH, 2016. THIS WILL IMPACT ON AVERAGE, TWELVE MDRS REPORTS FILED ANNUALLY. IF THERE ARE ANY QUESTIONS OR CONCERNS REGARDING THIS LETTER, PLEASE CONTACT US VIA EMAIL AT (B)(4).

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT A SURGICAL MARKING PEN WAS FOUND WITH DEFECTIVE SEALS. THE ITEM WAS NOT IN USE. NO INJURY/DEATH WAS REPORTED. THE REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM UNDER NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT PRODUCT WAS FOUND WITH SEAL ISSUES. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THE MANUFACTURING LOT NUMBER WAS PROVIDED FOR REVIEW. THE DISTRIBUTOR INDICATED THAT THE DEFECTS WERE FOUND DURING INCOMING INSPECTION. A REVIEW OF THE SAMPLES CONFIRMED THE ISSUE FROM THE DISTRIBUTOR. ANALYSIS OF THE FINISHED GOOD LOT NUMBER WAS REVIEWED. NO NON-CONFORMANCE'S WERE NOTED DURING THE MANUFACTURING PROCESS. A REVIEW OF THE SAMPLE CONFIRMED THE REPORTED PROBLEM OF PART IN SEAL. THE PRODUCTION LINES USE AN AUTO-LOADER SYSTEM TO DISPENSE THE LABELS. WHEN THE MACHINE IS SHUT DOWN SUDDENLY, THE LABELS CAN FALL OUT OF THE POCKET, OR ADDITIONAL LABELS CAN BE DISPENSED. ON A SUDDEN SHUTDOWN, OPERATORS ARE REQUIRED TO REVIEW PRODUCT FOR PARTS IN SEAL. ROOT CAUSE IS THEREFORE OPERATOR ERROR. PRODUCTION TEAM WAS NOTIFIED OF THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT A SURGICAL MARKING PEN WAS FOUND WITH DEFECTIVE SEALS. THE ITEM WAS NOT IN USE. NO INJURY/DEATH WAS REPORTED. THE REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM UNDER NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231958 MURANAKA SURGICAL MARKING PEN W;/RULER AND 6-UP LABELS, STERILE MARKING PEN FZZ ASPEN SURGICAL PRODUCTS, CALEDONIA MMI02730PBX 242949

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown