MAUDE Adverse Event Report: SALTER LABS ADULT SOFT TIP CANNULA; ADULT SOFT TIP CANNULA WITH 7' 85 SHORE GREEN TUBING,

Model Number	0556
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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 second of two reports.Refer to 3004748541-2025-00036 for the first 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.].
Additional Manufacturer Narrative
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 (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.
Event or Problem Description
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 second of two reports.Refer to 3004748541-2025-00036 for the first 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.].
Additional Manufacturer Narrative
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.

• Brand Name: ADULT SOFT TIP CANNULA
• Common Device Name: ADULT SOFT TIP CANNULA WITH 7' 85 SHORE GREEN TUBING,
• Manufacturer (Section D): SALTER LABS; 30 spur dr; el paso TX
• Manufacturer (Section G): SALTER LABS; 30 spur dr; el paso TX
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 22617400
• Report Number: 3004748541-2025-00037
• Device Sequence Number: 8166572
• Product Code: CAT
• UDI-Device Identifier: 00709078002960
• UDI-Public: (01)00709078002960(10)534041(11)250203(17)300203
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0556
• Device Lot Number: 534041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male