BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 19638772 · Received June 28, 2024

    Report

    Report Number
    3000219639-2024-00056
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    May 29, 2024
    Report Date
    August 21, 2025
    Manufacturer
    SALTER LABS
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 28 JUNE 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT 09702. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT - (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. THIS COMPLAINT INVESTIGATION WILL BE DOCUMENTED UNDER CAPA-00592 FOR FURTHER INVESTIGATION OF THE CANNULAIDS ISSUE. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.

    Description of Event or Problem · 0

    WE HAVE ENCOUNTERED WITH YOUR CPAP CANNULAIDE SECUREMENT DEVICES OVER THE PAST SEVERAL MONTHS. AS A LEADING HEALTHCARE PROVIDER IN (B)(6) GEORGIA, COMPRISED OF FIVE HOSPITALS, WE HAVE NOTICED A DISTRESSING INCREASE IN SKIN BREAKDOWN AMONG OUR NEONATAL INTENSIVE CARE UNIT (NICU) PATIENTS WHO RELY ON BUBBLE CPAP AND NON-INVASIVE VENTILATION, PARTICULARLY THOSE USING THE NEWER LOT NUMBERS. HAS THERE BEEN A CHANGE IN FORMULATION DURING THE MANUFACTURING PROCESS? IT APPEARS THAT RECENT MANUFACTURING CHANGES TO THE PRODUCT HAVE INADVERTENTLY MADE THE CANNULAIDE MUCH MORE CHALLENGING TO REMOVE FROM THE INFANT'S DELICATE FACIAL SKIN. THIS INCREASED DIFFICULTY HAS RESULTED IN HEIGHTENED INSTANCES OF SKIN ABRASIONS, BLEEDING, AND BRUISING, CAUSING UNDUE DISCOMFORT AND POTENTIAL COMPLICATIONS FOR OUR VULNERABLE PATIENTS. THE WELFARE OF OUR INFANTS IS OUR UTMOST PRIORITY, AND IT IS DISTRESSING TO WITNESS THE ADVERSE EFFECTS OF THESE CHANGES ON THEIR WELL-BEING. AS A RESULT, WE ARE COMPELLED TO REACH OUT TO YOU IN THE HOPE OF FINDING A RESOLUTION THAT ENSURES THE CONTINUED SAFETY AND COMFORT OF OUR TINY PATIENTS. WE KINDLY REQUEST YOUR URGENT ATTENTION TO THIS MATTER AND SEEK CLARIFICATION ON ANY ALTERATIONS MADE TO THE MANUFACTURING PROCESS OF THE INFANT CPAP CANNULAIDE SECUREMENT DEVICES, PARTICULARLY TO THE ADHESIVE PRODUCTS YOU HAVE INTRODUCED SINCE ACQUIRING THIS PRODUCT LINE. ADDITIONALLY, WE WOULD APPRECIATE ANY INSIGHTS OR RECOMMENDATIONS YOU MAY HAVE ON MITIGATING THE RISK OF SKIN BREAKDOWN ASSOCIATED WITH THE CURRENT PRODUCT DESIGN. OUR GOAL IS TO PROVIDE THE BEST POSSIBLE CARE TO OUR PATIENTS, AND WE BELIEVE THAT OPEN COMMUNICATION AND COLLABORATION WITH MANUFACTURERS LIKE YOURSELVES ARE ESSENTIAL IN ACHIEVING THIS OBJECTIVE. WE SINCERELY HOPE THAT TOGETHER WE CAN FIND A SOLUTION THAT ADDRESSES THESE CONCERNS AND ALLOWS US TO CONTINUE UTILIZING YOUR PRODUCT EFFECTIVELY IN OUR NICU.

    Description of Event or Problem · 0

    WE HAVE ENCOUNTERED WITH YOUR CPAP CANNULAIDE SECUREMENT DEVICES OVER THE PAST SEVERAL MONTHS. AS A LEADING HEALTHCARE PROVIDER IN (B)(6), COMPRISED OF FIVE HOSPITALS, WE HAVE NOTICED A DISTRESSING INCREASE IN SKIN BREAKDOWN AMONG OUR NEONATAL INTENSIVE CARE UNIT (NICU) PATIENTS WHO RELY ON BUBBLE CPAP AND NON-INVASIVE VENTILATION, PARTICULARLY THOSE USING THE NEWER LOT NUMBERS. HAS THERE BEEN A CHANGE IN FORMULATION DURING THE MANUFACTURING PROCESS? IT APPEARS THAT RECENT MANUFACTURING CHANGES TO THE PRODUCT HAVE INADVERTENTLY MADE THE CANNULAIDE MUCH MORE CHALLENGING TO REMOVE FROM THE INFANT'S DELICATE FACIAL SKIN. THIS INCREASED DIFFICULTY HAS RESULTED IN HEIGHTENED INSTANCES OF SKIN ABRASIONS, BLEEDING, AND BRUISING, CAUSING UNDUE DISCOMFORT AND POTENTIAL COMPLICATIONS FOR OUR VULNERABLE PATIENTS. THE WELFARE OF OUR INFANTS IS OUR UTMOST PRIORITY, AND IT IS DISTRESSING TO WITNESS THE ADVERSE EFFECTS OF THESE CHANGES ON THEIR WELL-BEING. AS A RESULT, WE ARE COMPELLED TO REACH OUT TO YOU IN THE HOPE OF FINDING A RESOLUTION THAT ENSURES THE CONTINUED SAFETY AND COMFORT OF OUR TINY PATIENTS. WE KINDLY REQUEST YOUR URGENT ATTENTION TO THIS MATTER AND SEEK CLARIFICATION ON ANY ALTERATIONS MADE TO THE MANUFACTURING PROCESS OF THE INFANT CPAP CANNULAIDE SECUREMENT DEVICES, PARTICULARLY TO THE ADHESIVE PRODUCTS YOU HAVE INTRODUCED SINCE ACQUIRING THIS PRODUCT LINE. ADDITIONALLY, WE WOULD APPRECIATE ANY INSIGHTS OR RECOMMENDATIONS YOU MAY HAVE ON MITIGATING THE RISK OF SKIN BREAKDOWN ASSOCIATED WITH THE CURRENT PRODUCT DESIGN. OUR GOAL IS TO PROVIDE THE BEST POSSIBLE CARE TO OUR PATIENTS, AND WE BELIEVE THAT OPEN COMMUNICATION AND COLLABORATION WITH MANUFACTURERS LIKE YOURSELVES ARE ESSENTIAL IN ACHIEVING THIS OBJECTIVE. WE SINCERELY HOPE THAT TOGETHER WE CAN FIND A SOLUTION THAT ADDRESSES THESE CONCERNS AND ALLOWS US TO CONTINUE UTILIZING YOUR PRODUCT EFFECTIVELY IN OUR NICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851498 SALTER LABS CPAP CANNULAIDE-EXACT DEVIE IS UNKNOWN BZD SALTER LABS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other