BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING PIPETTE

    MDR report key: 11802782 · Received May 10, 2021

    Report

    Report Number
    1216677-2021-00098
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    January 27, 2021
    Report Date
    February 23, 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: INITIATED INVESTIGATION: NO SAMPLE RETURNED. *ANALYSIS AND FINDINGS: DISTRIBUTION HISTORY: IT COULD NOT BE DETERMINED WHEN THE COMPLAINT PRODUCT WAS MANUFACTURED. THE 7-71-32H30 IS A PART NUMBER THAT WAS MANUFACTURED BY AUSTRALIA FACILITY, WHICH IS NOT LONGER ACTIVE. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT/SERIAL NUMBER OF THE COMPLETED UNIT WAS NOT PROVIDED CORRECTLY. IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE COMPLAINT PRODUCT LOT/SERIAL NUMBER BE PROVIDED GOING FORWARD, THE DEVICE HISTORY RECORD WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. 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: 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: 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

    MULTIPLE REPORTS OF A "LAB INFECTION" "ACROSS MULTIPLE PATIENTS." 1216677-2021-00098-1-HOLDING PIPETTE 7-71-32H30 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE CONDITION REPORTED.

    Description of Event or Problem · 1

    MULTIPLE REPORTS ON TIPS & PIPETTE SUBMITTED BY CSI (B)(4). 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). HOLDING PIPETTE 7-71-32H30. E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700002 HOLDING PIPETTE HOLDING PIPETTE MQH COOPERSURGICAL, INC. 7-71-32H30 4235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other