BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT SOFT TIP CANNULA

    MDR report key: 22617428 · Received July 25, 2025

    Report

    Report Number
    3004748541-2025-00036
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    June 22, 2025
    Report Date
    September 4, 2025
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    UDI-DI
    00709078002960
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION-INVESTIGATION CONCLUSION: D4; H4; H6. H6: (APPROPRIATE TERM/CODE NOT AVAILABLE): 3191- THE TUBE WAS PINCHED. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE REPORTER PROVIDED PHOTOGRAPHIC/VIDEOGRAPHIC EVIDENCE; ANALYSIS OF THE PHOTOGRAPHIC EVIDENCE CONFIRMED THE COMPLAINT AS REPORTED; THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 534041 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 04 SEP 2025 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 SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (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 SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    H6: (APPROPRIATE TERM/CODE NOT AVAILABLE): 3191- THE TUBE WAS PINCHED. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 25 JUL 2025 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 SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS 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 SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3004748541-2025-00037 FOR THE SECOND REPORT. IT WAS REPORTED: REPORTED: [WHILE] GIVING VETERAN HIS MEDICATION AND TALKING TO VETERAN WRITER NOTICED VETERAN'S OXYGEN TUBING PRONG BY [NOSE] WAS PINCHED. WRITER ASKED VETERAN IF VET COULD FEEL AIR COMING OUT. VETERAN TESTED IT AND SAID NO. THIS HAS BEEN HAPPENING VERY FREQUENTLY. WRITER GOT A NEW NASAL CANNULA AND THAT ONE WAS THE SAME WAY, FINALLY GOT ANOTHER ONE AND IT WAS USABLE. IT WAS ADDITIONALLY REPORTED, THE PATIENT WAS NOT RECEIVING THE CORRECT DOSE OF OXYGEN THROUGH CANNULA. ON THE SPOT CORRECTION BY NURSING. NO ADVERSE AFFECTS TO PATIENT WERE RECORDED. FDA USER FACILITY MW REPORT MW5172094, RECEIVED ON 15JUL2025 REPORTED, VETERAN IS ON 3L OF O2 AND NOW IS ABLE TO GET THE AMOUNT OF OXYGEN VET NEEDS. REF REPORT: MW5172095. [THERE WAS NO REPORTED INJURY.]

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3004748541-2025-00037 FOR THE SECOND REPORT IT WAS REPORTED: REPORTED: [WHILE] GIVING VETERAN HIS MEDICATION AND TALKING TO VETERAN WRITER NOTICED VETERAN'S OXYGEN TUBING PRONG BY [NOSE] WAS PINCHED. WRITER ASKED VETERAN IF VET COULD FEEL AIR COMING OUT. VETERAN TESTED IT AND SAID NO. THIS HAS BEEN HAPPENING VERY FREQUENTLY. WRITER GOT A NEW NASAL CANNULA AND THAT ONE WAS THE SAME WAY, FINALLY GOT ANOTHER ONE AND IT WAS USABLE. IT WAS ADDITIONALLY REPORTED, THE PATIENT WAS NOT RECEIVING THE CORRECT DOSE OF OXYGEN THROUGH CANNULA. ON THE SPOT CORRECTION BY NURSING. NO ADVERSE AFFECTS TO PATIENT WERE RECORDED. FDA USER FACILITY MW REPORT MW5172094, RECEIVED ON 15JUL2025 REPORTED, VETERAN IS ON 3L OF O2 AND NOW IS ABLE TO GET THE AMOUNT OF OXYGEN VET NEEDS. REF REPORT: MW5172095. [THERE WAS NO REPORTED INJURY.]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756628 ADULT SOFT TIP CANNULA ADULT SOFT TIP CANNULA WITH 7' 85 SHORE GREEN TUBING CAT SALTER LABS 0556 534041 00709078002960

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male