MAUDE Adverse Event Report: SALTER LABS SALTER LABS; CANNULA, ADULT CONVENTIONAL, OXYGEN W/3-CHANNEL TUBE 7' - 50/CS

Model Number	1053-7-50
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Defected bonded between the glasses and the tubing. .
Additional Manufacturer Narrative
The patient could desaturate because of interrupted oxygen delivery.
Event or Problem Description
Defected bonded between the glasses and the tubing. .
Additional Manufacturer Narrative
The patient could desaturate because of interrupted oxygen delivery.Complaint history reviewed.There has been 1 similar complaint for 1053-x cannula in the previous 24 months.(cc-08087).No returned material, no pictures of defective material, no remaining lot# in inventory.Complaint cannot be confirmed.Most likely root cause is not enough bonding agent was applied to the tubing during assembly, and bond strength failed during use.Bond may deteriorate faster due to improper storage or handling of the cannula during transit and use.Risk(rma-20017a): r26: oxygen delivery interrupted - cannula components not bonded together securely - s=8 o=2 rpn=16.Rpn < 25, therefore risk is acceptable.Issue has been added to precarb review spreadsheet.

• Brand Name: SALTER LABS
• Common Device Name: CANNULA, ADULT CONVENTIONAL, OXYGEN W/3-CHANNEL TUBE 7' - 50/CS
• 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: 16918957
• Report Number: 3000219639-2023-00012
• Device Sequence Number: 6930274
• Product Code: CAT
• UDI-Device Identifier: 10607411101110
• UDI-Public: 10607411101110
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1053-7-50
• Device Catalogue Number: 1053-7-50
• Device Lot Number: 10211213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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