BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-TIP WITH 290 MICRON

    MDR report key: 11739682 · Received April 28, 2021

    Report

    Report Number
    1216677-2021-00077
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    January 27, 2021
    Report Date
    March 9, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MQH
    PMA / PMN Number
    K161275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION NO SAMPLE RETURNED REVIEW DHR ANALYSIS AND FINDINGS: "DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 17TH MARCH 2020. MANUFACTURING RECORD REVIEW DHR WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. NO OTHER COMPLAINTS REPORTED THAT RELATE TO THIS LOT NUMBER. INCOMING INSPECTION REVIEW INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTION AND/OR CORRECTIVE ACTION NO OTHER COMPLAINTS REPORTED THAT RELATE TO THIS LOT NUMBER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? NO.

    Additional Manufacturer Narrative · 0

    *ANALYSIS AND FINDINGS "DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 17TH MARCH 2020. MANUFACTURING RECORD REVIEW DHR WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. NO OTHER COMPLAINTS REPORTED THAT RELATE TO THIS LOT NUMBER. INCOMING INSPECTION REVIEW INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. *CORRECTION AND/OR CORRECTIVE ACTION NO OTHER COMPLAINTS REPORTED THAT RELATE TO THIS LOT NUMBER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. *WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    THEY HAVE HAD A LAB INFECTION. THIS IS ACROSS MULTIPLE PATIENTS. 1216677-2021-00077-1 EZ-TIP WITH 290 MICRON 7-72-4290 20 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    THEY HAVE HAD A LAB INFECTION. THIS IS ACROSS MULTIPLE PATIENTS. EZ-TIP WITH 290 MICRON 7-72-4290 20 E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE CONDITION REPORTED.

    Description of Event or Problem · 1

    INCIDENT DETAIL: THEY HAVE HAD A LAB INFECTION. THIS IS ACROSS MULTIPLE PATIENTS. THEY SUSPECT THAT THE MOST LIKELY SOURCE IS THE GTL MEDIA FROM VL. THIS IS BASED ON ONE OTHER REPORT FROM A CLINIC (B)(6) KNOWS. THEY NEED TO HOWEVER WORK THROUGH A PROCESS OF ELIMINATION AND WILL LIKE TO SEE IF WE HAVE HAD ANY REPORTS ON THE ITEMS LISTED, THEY ARE IN COMMON IN THE INFECTED PATIENTS TREATMENT CYCLES. I DO NOT WANT TO PUT PROCEED WITH A COMPLAINT AS I DO NOT SEE THIS AS A COMPLAINT BUT AN INVESTIGATION, HOWEVER, WILL TAKE DIRECTION FROM YOU AS TO HOW IT MAY BEST TO CAPTURE THE SITUATION AND ALSO THE SPECIFICS OF THE COMMUNICATION TO THE CUSTOMER. CUSTOMER JUST WISHES TO KNOW IF ANY ITEMS FROM THESE LOTS HAVE ALSO BEEN INVESTIGATED FOR INFECTION - NO ACTUAL COMPLAINT HERE. CUSTOMER CONTACT- (B)(6). 1216677-2021-00077 EZ-TIP WITH 290 MICRON 7-72-4290-20 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639025 EZ-TIP WITH 290 MICRON EZ-TIP WITH 290 MICRON MQH COOPERSURGICAL, INC. 7-72-4290/20 209221

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other