BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEO-FIT NEONATAL ENDOTRAC

    MDR report key: 11612863 · Received April 5, 2021

    Report

    Report Number
    1216677-2021-00060
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    February 25, 2021
    Report Date
    April 4, 2021
    Manufacturer
    COOPERSURGICAL INC.
    Product Code
    JAY
    PMA / PMN Number
    EXEMPT
    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: X-REVIEW DHR/ X-INSPECT RETURNED SAMPLES: *ANALYSIS AND FINDINGS: DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS ASSEMBLED AT CSI IN SEPTEMBER 2020 UNDER WORK ORDER (B)(4). MANUFACTURING RECORD REVIEW: DHR (B)(4) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. 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 (1 PIECE NOT IN ORIGINAL PACKAGE AND 9 PIECES IN ORIGINAL PACKAGING VIAL WITH LABEL) WERE RETURNED. THE LOT NUMBER OF THE RETURNED PRODUCT MATCHED THE LOT NUMBER REPORTED. VISUAL EVALUATION: VISUAL EXAMINATION OF THE 1 PIECE NOT IN THE ORIGINAL PACKAGING WAS CONDUCTED AND IS ASSUMED TO BE THE COMPLAINT PRODUCT. INVESTIGATION FOUND ONE OF THE TWO STAPLES WAS DETACHED FROM THE STRAP. THE DETACHED STAPLE HAD ONE LEG LIFTED HIGHER THAN THE OTHER LEG, WHICH WAS PARALLEL. VISUAL EXAMINATION OF THE 9 PIECES IN THE ORIGINAL PACKAGING REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND THE 1 PIECE NOT IN THE ORIGINAL PACKAGING WAS FOUND NOT TO FUNCTION PROPERLY AS ONE STAPLE WAS DETACHED FROM THE STRAP. A SAMPLE OF THE 9 PIECES IN THE ORIGINAL PACKAGING VIAL FUNCTIONED PROPERLY. ROOT CAUSE: WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE POTENTIAL CAUSE MAY BE DUE TO MISHANDLING OF THE PRODUCT AFTER LEAVING THE MANUFACTURING FACILITY AS THE STAPLE HAD ONE LEG LIFTED HIGHER THAN THE OTHER. THIS MAY HAVE CAUSED THE STAPLE TO BECOME LOOSE AND DETACH FROM THE STRAP. PRIOR TO PACKAGING, IT SHOULD BE NOTED THAT EACH ASSEMBLY IS INSPECTED BY GRASPING THE HOLDER AND SLIGHTLY PULLING ON THE STRAP. IF THE STRAP PULLS OFF THE SHOULDER OR IF THE STAPLES MOVE ON THE STRAP THEN THE ASSEMBLY IS REJECTED. *CORRECTION AND/OR CORRECTIVE ACTION: NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME. NO TRAINING REQUIRED AT THIS TIME. *PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    (B)(4). ADDITIONAL REPORT IN REF. TO (B)(4). REPORT SUBMITTED BY DISTRIBUTOR- WE HAVE RECEIVED A COMPLAINT REGARDS YOUR PRODUCT 211710-437747 NEO-FIT-ET TUBE HOLDER, BATCH 296236 THAT 6 OUT OF 20 BOXES HAD A LOOSE METAL PART OF TUBE. NEONATAL TUBE GRIP CAME LOOSE FROM THE ETT, AND A METAL PART OF TUBE HOLDER WAS FOUND INSIDE THE BABY'S MOUTH. NO HARM TO A BABY WAS REPORTED, BUT THIS INCIDENT WAS REPORTED TO NOTIFIED REGULATORY BODY MHRA AND WILL REQUIRE FURTHER ACTION FROM YOU. FOLLOW-UP INITIATED FOR ADDITIONAL INFORMATION. 03/09/2021-PER ADDITIONAL INFORMATION- QTY: 6 OUT OF 20 N4225/40 (211710-437747) BATCH 292889 SMALL METAL CLIP DETACHED FROM GRIP & ENDED UP LOOSE IN THE BABIES MOUTH. THE LOOSE CLIP & FAULTY GRIP WERE REMOVED & A NEW GRIP ATTACHED TO THE ET TUBE. DURING USE, NO HARM TO BABY. THIS INCIDENT HAS BEEN REPORTED TO MHRA. 1216677-2021-00060 NEO-FIT NEONATAL ENDOTRAC 42-2540 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION .

    Description of Event or Problem · 1

    E-COMPLAINT-(B)(4). ADDITIONAL REPORT IN REF. TO E-COMPLAINT-(B)(4). REPORT SUBMITTED BY DISTRIBUTOR- WE HAVE RECEIVED A COMPLAINT REGARDS YOUR PRODUCT 211710-437747 NEO-FIT-ET TUBE HOLDER, BATCH 296236 THAT 6 OUT OF 20 BOXES HAD A LOOSE METAL PART OF TUBE. NEONATAL TUBE GRIP CAME LOOSE FROM THE ETT, AND A METAL PART OF TUBE HOLDER WAS FOUND INSIDE THE BABY'S MOUTH. NO HARM TO A BABY WAS REPORTED, BUT THIS INCIDENT WAS REPORTED TO NOTIFIED REGULATORY BODY MHRA AND WILL REQUIRE FURTHER ACTION FROM YOU. FOLLOW-UP INITIATED FOR ADDITIONAL INFORMATION. 03/09/2021-PER ADDITIONAL INFORMATION- QTY: 6 OUT OF 20 N4225/40 (211710-437747) BATCH 292889 SMALL METAL CLIP DETACHED FROM GRIP & ENDED UP LOOSE IN THE BABIES MOUTH. THE LOOSE CLIP & FAULTY GRIP WERE REMOVED & A NEW GRIP ATTACHED TO THE ET TUBE. DURING USE, NO HARM TO BABY. THIS INCIDENT HAS BEEN REPORTED TO MHRA. NEO-FIT NEONATAL ENDOTRAC 42-2540 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513765 NEO-FIT NEONATAL ENDOTRAC NEO-FIT NEONATAL ENDOTRAC JAY COOPERSURGICAL INC. 42-2540 292889

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other