MAUDE Adverse Event Report: SALTER LABS NASAL CANNULA (ADULT) WITH 7' (2.1 M) SUPPLY TUBE; CANNULA, ADULT CONVENTIONAL, OXYGEN W/3-CHANNEL TUBE; O2 DELIVERY

Model Number	1053-7-50
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided.The actual complaint product was not available for return; however, the customer provided photo images of the issue.Based on the photo image provided the complaint was confirmed for tube disconnected from the nasal tip.Without a sample to perform functional evaluation, the root cause cannot be determined.All information reasonably known as of 15 may 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 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.
Event or Problem Description
It was reported, the patient's tube [which was] connected to the nasal tips came off after a couple of days.The device was in use at the patient's home; there was no reported injury.

• Brand Name: NASAL CANNULA (ADULT) WITH 7' (2.1 M) SUPPLY TUBE
• Common Device Name: CANNULA, ADULT CONVENTIONAL, OXYGEN W/3-CHANNEL TUBE; O2 DELIVERY
• Manufacturer (Section D): SALTER LABS; 30 spur dr; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur dr; el paso TX 79906
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544 ; 2054826767
• MDR Report Key: 19326267
• Report Number: 3000219639-2024-00040
• Device Sequence Number: 2582116
• Product Code: CAT
• UDI-Device Identifier: 10607411101110
• UDI-Public: 10607411101110
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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: Lay User/Patient
• Device Model Number: 1053-7-50
• Device Catalogue Number: I EA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown