BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEO-FIT NEONATAL ENDOTRAC

    MDR report key: 15094252 · Received July 25, 2022

    Report

    Report Number
    1216677-2022-00216
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    July 10, 2022
    Report Date
    November 11, 2022
    Manufacturer
    COOPERSURGICAL INC.
    Product Code
    JAY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION. NO SAMPLE RETURNED. ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THE NEO-FIT NEONATAL ENDOTRACHEAL PRODUCT IS MANUFACTURED AT CSI. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AT TIME OF THIS INVESTIGATION. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS. SHOULD THE LOT NUMBER BE PROVIDED AT A LATER DATE THE DEVICE HISTORY RECORD CAN BE LOCATED AND THIS COMPLAINT WILL BE AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NOT APPLICABLE. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: NOT APPLICABLE. PRODUCT WAS NOT RETURNED. VISUAL EVALUATION: A VISUAL EVALUATION COULD NOT BE COMPLETED AS THE COMPLAINT UNIT CANNOT BE RETURNED TO COOPERSURGICAL. FUNCTIONAL EVALUATION: AN FUNCTIONAL EVALUATION COULD NOT BE COMPLETED AS THE COMPLAINT UNIT CANNOT BE RETURNED TO COOPERSURGICAL. HOWEVER, UNITS IN FG WERE SUFFICIENT TO DETECT A PROBLEM AND RELEVANT TO THIS COMPLAINT. ROOT CAUSE: AN INVESTIGATION HAS DETERMINED THE ROOT CAUSE IS DUE TO A DEFECTIVE COMPONENT THAT MAY LEND ITSELF TO BREAKING OFF. GIVEN THE POTENTIAL FOR BREAKAGE EXISTS, THE RIDE IN THE HELICOPTER MAY HAVE EXACERBATED THE POTENTIAL FOR BREAKAGE. HOWEVER, THE HELICOPTER RIDE IS NOT DEEMED A SIGNIFICANT CONTRIBUTING FACTOR WHERE THE WEAK SPOT ON THE CLIP IS. CORRECTION AND/OR CORRECTIVE ACTION: A REVIEW OF THE PROCESS DURING ASSEMBLY CONFIRMS THE CLIPS ARE OF STAINLESS STEEL AND PUT IN PLACE WITH THE USE OF A PRESS SPECIFICALLY DESIGNED TO SECURELY HOLD ALL RELEVANT COMPONENTS IN PLACE. FURTHER REVIEW OF COMPONENT 005-052 REVEALED A DEFECT WHERE THE CORNERS WERE NOTED TO BE OUT OF SPECIFICATION UNDER A NON-ROUTINE INSPECTION. A SCAR WAS ISSUED TO THE VENDER UNDER NCMR-2022-09-003 WHICH PULLED ALL SK MATERIAL TO MR. WORK ORDERS (B)(4) IN WIP WERE PLACED ON HOLD. A SAMPLING FROM 2 LOTS WERE PULLED ((B)(4)) FROM FG AND CONFIRMED TO HAVE THE SAME WEAK SPOT ON THE CLIP ENDS. A REGULATORY HOLD WAS PLACED ON THIS PRODUCT AND AN HHE WAS GENERATED. FINAL DISPOSITION OF PRODUCT ON HOLD TO BE DETERMINED UNDER CAPA 793 WHICH WAS ISSUED TO COMPLETE THE INVESTIGATION AND CORRECTIVE ACTIONS. REFERENCE: RECALL 1216677-10/12/2022-001-R. PREVENTATIVE ACTION ACTIVITY REFERENCE: CAPA 793.

    Description of Event or Problem · 0

    WE RECENTLY HAD A PRODUCT FAILURE IN THE NICU AT (B)(6). MY UNDERSTANDING IS THAT ONE OF THE SMALL METAL PIECES YOU CAN SEE CRIMPED OVER THE FABRIC WAS FOUND IN THE BABY'S THROAT. IT CUT THE THROAT. BABY INTUBATED FOR MECHANICAL VENTILATION AT (B)(6). SECURED TUBE USING "NEO-FIT NEONATAL ENDOTRACHEAL TUBE GRIP" (COOPER SURGICAL) PRODUCT THAT IS STOCKED IN OUR SUPPLY ROOM. CXR WAS OBTAINED, TUBE POSITION WAS ADJUSTED X 1 AND CXR WAS RETAKEN (THIS 2ND FILM WAS THE ONE SENT TO RADIOLOGY/EPIC). 3 METAL PIECES APPEAR VISIBLE ON DEVICE IN X RAY. BABY WAS TRANSPORTED BY AIRLIFE TEAM. THE TEAM MENTIONED RESECURING VS REPLACING THE SECUREMENT DEVICE AS THEY WERE APPROACHING DEPARTURE FROM (B)(6) NICU BUT IT IS UNCLEAR WHETHER THEY FURTHER SECURED OUR NEO-FIT OR USED THEIR OWN DEVICE. WHEN BABY ARRIVED AT (B)(6) IN (B)(6) THE TEAM NOTED BLOOD IN THE MOUTH AND UPON INVESTIGATION DISCOVERED A PIECE OF METAL THAT MATCHES THE METAL PIECES THAT ARE PART OF THE NEOFIT DEVICE. 1216677-2022-00216 NEO-FIT NEONATAL ENDOTRAC 42-2540 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    WE RECENTLY HAD A PRODUCT FAILURE IN THE NICU AT (B)(6). MY UNDERSTANDING IS THAT ONE OF THE SMALL METAL PIECES YOU CAN SEE CRIMPED OVER THE FABRIC WAS FOUND IN THE BABY'S THROAT. IT CUT THE THROAT. BABY INTUBATED FOR MECHANICAL VENTILATION AT MRMC. SECURED TUBE USING "NEO-FIT NEONATAL ENDOTRACHEAL TUBE GRIP" (COOPER SURGICAL) PRODUCT THAT IS STOCKED IN OUR SUPPLY ROOM. CXR WAS OBTAINED, TUBE POSITION WAS ADJUSTED X 1 AND CXR WAS RETAKEN (THIS 2ND FILM WAS THE ONE SENT TO RADIOLOGY/EPIC). 3 METAL PIECES APPEAR VISIBLE ON DEVICE IN X RAY. BABY WAS TRANSPORTED BY AIRLIFE TEAM. THE TEAM MENTIONED RESECURING VS REPLACING THE SECUREMENT DEVICE AS THEY WERE APPROACHING DEPARTURE FROM MRMC NICU BUT IT IS UNCLEAR WHETHER THEY FURTHER SECURED OUR NEO-FIT OR USED THEIR OWN DEVICE. WHEN BABY ARRIVED AT SFMC IN CO SPRINGS THE TEAM NOTED BLOOD IN THE MOUTH AND UPON INVESTIGATION DISCOVERED A PIECE OF METAL THAT MATCHES THE METAL PIECES THAT ARE PART OF THE NEOFIT DEVICE. 1216677-2022-00216 NEO-FIT NEONATAL ENDOTRAC 42-2540 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667733 NEO-FIT NEONATAL ENDOTRAC NEO-FIT NEONATAL ENDOTRAC JAY COOPERSURGICAL INC. 42-2540 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other