MAUDE Adverse Event Report: SALTER LABS SALTER LABS; CANNULA, ADULT CONVENTIONAL, OXYGEN W/3-CHANNEL TUBE 50'

Model Number	1053-50
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient had an allergic reaction.
Event or Problem Description
Abundant epistaxis, breaking of nasal capillaries. .
Additional Manufacturer Narrative
The patient had an allergic reaction.The complaint of "feeling of hardness and lack of adhesion of the cannula to the nasal mucosa during oxygen intake" were reported.There were no lot number to perform an inventory analysis, no photo images, or videos provided for product evaluation.The root cause was unable to be identified at this time.A risk assessment was performed, and the ultimate risk was determined to be low which does not require reporting to the capa review board.This is the first complaint within the 24 months for part number (b)(6) "skin irritation/reaction.We will continue to monitor trends during our periodic complaint review meetings.
Event or Problem Description
Abundant epistaxis, breaking of nasal capillaries. .

• Brand Name: SALTER LABS
• Common Device Name: CANNULA, ADULT CONVENTIONAL, OXYGEN W/3-CHANNEL TUBE 50'
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18842480
• Report Number: 3000219639-2024-00020
• Device Sequence Number: 8344199
• Product Code: CAT
• UDI-Device Identifier: 10607411101110
• UDI-Public: 10607411101110
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1053-50
• Device Catalogue Number: 1053-50
• Device Lot Number: UNKNOWN
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/18/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown