BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITYVAC M-STYLE CUP

    MDR report key: 6932803 · Received October 9, 2017

    Report

    Report Number
    1216677-2017-00065
    Event Type
    Injury
    Date Received
    October 9, 2017
    Report Date
    November 10, 2017
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HDB
    PMA / PMN Number
    K890307
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL IS CURRENTLY INVESTIGATING THE COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. REFERENCE E-COMPLAINT-(B)(4). UPDATE 11/10/17: INVESTIGATION: ANALYSIS AND FINDINGS: THE REPORTED EVENT THAT THE CUP DISCONNECTED FROM THE TUBING CANNOT BE PHYSICALLY CONFIRMED AS THE AFFECTED DEVICE WILL NOT BE RETURNED, HOWEVER, IF THE DEVICE IS RETURNED IN THE FUTURE AND MADE AVAILABLE FOR INVESTIGATIVE ANALYSIS, THE COMPLAINT MAY BE REOPENED AND ADDRESSED AS NEEDED. THE ROOT CAUSE OF THE DISCONNECTION IS INDETERMINABLE. A REVIEW OF THE LOT DHR DID NOT REVEAL ANY ABNORMALITY, SEE ATTACHED. A REVIEW OF THE MANUFACTURING PROCESS WAS NOTED TO BE IN-CONTROL, AND UNALTERED. FURTHER EVALUATION FOR CONTINUOUS IMPROVEMENTS WILL BE PERFORMED, AND ANY FEASIBLE OR REQUIRED ASSEMBLY PROCESS ENHANCEMENT WILL BE CONSIDERED FOR IMPLEMENTATION. INVENTORY REVIEW INDICATED NO FURTHER AVAILABILITY OF LOT NUMBER 210279 FOR FURTHER EVALUATION. CORRECTIVE ACTIONS: CORRECTION AND/OR CORRECTIVE ACTION: DUE TO THE PHYSICAL AFFECTED DEVICE NOT HAVING BEEN RETURNED, ROOT CAUSE BEING INDETERMINABLE AND ALL INSPECTION DATA INDICATING THE SUPPLIER RAW MATERIAL LOTS USED IN WORK ORDER (B)(4) MET ALL ASSOCIATED REQUIREMENTS. REASON: (B)(4), THIS COMPLAINT WILL BE MONITORED FOR TRENDING IN THAT NO INJURY WAS REPORTED TO END USER OR PATIENT. WAS THE COMPLAINT CONFIRMED? NO.

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL IS CURRENTLY INVESTIGATING THE COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    "WE RECEIVED A CLAIM FROM A HOSPITAL OUR CUSTOMER THAT FOR THE SECOND TIME THEY HAD PROBLEMS WITH MITYVAC M-STYLE CUPS , CAT. NO. 1007LP, DURING THE DELIVERY. THEY CLAIM THAT AT THE MOMENT OF THE TRACTION THE CUP DISCONNECTED FROM THE TUBING CAUSING SOME LACERATIONS IN THE HEAD OF THE NEWBORN." REFERENCE E-COMPLAINT-(B)(4).

    Description of Event or Problem · 1

    "WE RECEIVED A CLAIM FROM A HOSPITAL OUR CUSTOMER THAT FOR THE SECOND TIME THEY HAD PROBLEMS WITH MITYVAC M-STYLE CUPS , CAT. NO. 1007LP, DURING THE DELIVERY. THEY CLAIM THAT AT THE MOMENT OF THE TRACTION THE CUP DISCONNECTED FROM THE TUBING CAUSING SOME LACERATIONS IN THE HEAD OF THE NEWBORN." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707512 MITYVAC M-STYLE CUP MITYVAC M-STYLE CUP HDB COOPERSURGICAL, INC. 10007LP 210279

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other