BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEO-FIT NEONATAL ENDOTRAC

    MDR report key: 8329607 · Received February 11, 2019

    Report

    Report Number
    1216677-2019-00038
    Event Type
    Malfunction
    Date Received
    February 11, 2019
    Date of Event
    December 31, 2018
    Report Date
    December 11, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    JAY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REF (B)(4). INVESTIGATION INTO COMPLAINTS (B)(4) INVOLVING THE NEO-FIT® NEONATAL ENDOTRACHEAL TUBE GRIP (P/N: 42-2540, LOTS: 234583, 247018, 234577, 243214, 234581, 247017, 234585, 247009, 247013, 247015, 234585, 247017, 247013, 243214, & 247015). THESE COMPLAINTS REGARDED THE FAILURE OF THE ADHESIVE FOAM PADS TO REMAIN SECURED TO THE INFANT'S FACE AND A LACK OF TUBE SECURITY WHEN WRAPPED WITH THE VELCRO® STRAP. PRODUCT SURVEILLANCE AND QUALITY ENGINEERING CONDUCTED AN EVALUATION OF THE NEO-FIT® NEONATAL ENDOTRACHEAL TUBE GRIP. THIS EVALUATION WAS BASED ON A REVIEW OF THE 2-YEAR COMPLAINT HISTORY, A DEVICE HISTORY RECORD (DHR) REVIEW, A REVIEW OF THE RETURNED PRODUCT, AND A REVIEW OF OUR SUPPLIER'S MATERIAL AND PROCESS. THE 2-YEAR COMPLAINT HISTORY REVIEW REVEALED 1 COMPLAINT SIMILAR IN NATURE IN WHICH THE CAUSE WAS FOUND TO BE INDETERMINABLE. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PRODUCTS INDICATED THE UNITS WERE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE AND DID NOT REVEAL ANY ABNORMALITIES. INVESTIGATION OF THE RETURNED PRODUCT REVEALED THE FACE/CHEEK PADS AND VELCRO® STRAP BOTH DISPLAYED ACCEPTABLE RETENTION STRENGTH. A REVIEW OF OUR SUPPLIER'S MATERIAL WITH REGARD TO THE ADHESIVE, VELCRO® STRAP, STAPLES AND ASSOCIATED MANUFACTURING PROCESS SHOWED NO CHANGES AND THAT THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. REGARDING CONCERNS OF THE PRODUCT'S SAFETY AND EFFICACY, COOPERSURGICAL HAS HEIGHTENED THE INCOMING INSPECTION CRITERIA FOR THE DEVICE . CORRECTION AND/OR CORRECTIVE ACTION: NONE. NO ALTERATION WAS MADE TO THE MANUFACTURING ASSEMBLY LINE OR IN MATERIALS IN THE WAY OF COMPONENTS OR RAW MATERIALS. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    REF (B)(4). PER CUSTOMER'S STATEMENT: TUBE AT DIFFERENT MARKING AT GUM OR LIP, DESATURATION, TUBE VISUALLY MOVING, VENTILATOR ALARMS, NOT SENSING BREATHS ON VENTILATOR, NO CHEST MOVEMENT." PLEASE NOTE THERE ARE ADDITIONAL COMPLAINTS RELATED TO THE REPORTED CONDITION FROM THIS FACILITY. FURTHER STATEMENT: "IN ALL THE EVENTS, THIS IS VARIED. SOME HAPPENED OUTSIDE OF ANY EVENT OR PROCEDURE AND WITH A SLEEPING PATIENT LAYING SUPINE IN BED. SOME OCCURRED WITH VOMITING, BATHING, KANGAROO CARE, BEFORE, DURING, OR AFTER THESE PROCEDURES."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REF (B)(4). PER CUSTOMER'S STATEMENT: TUBE AT DIFFERENT MARKING AT GUM OR LIP, DESATURATION, TUBE VISUALLY MOVING, VENTILATOR ALARMS, NOT SENSING BREATHS ON VENTILATOR, NO CHEST MOVEMENT. PLEASE NOTE THERE ARE ADDITIONAL COMPLAINTS RELATED TO THE REPORTED CONDITION FROM THIS FACILITY. FURTHER STATEMENT: "IN ALL THE EVENTS, THIS IS VARIED. SOME HAPPENED OUTSIDE OF ANY EVENT OR PROCEDURE AND WITH A SLEEPING PATIENT LAYING SUPINE IN BED. SOME OCCURRED WITH VOMITING, BATHING, KANGAROO CARE, BEFORE, DURING, OR AFTER THESE PROCEDURES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117774 NEO-FIT NEONATAL ENDOTRAC NEO-FIT JAY COOPERSURGICAL, INC. 42-2540 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other