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

Model Number 1053-7-50

Device Problem Material Integrity Problem (2978)

Patient Problem Hypoxia (1918)

Event Date 04/03/2023

Event Type  malfunction  

Event Description

Defected bonded between the glasses and the tubing. .

Manufacturer Narrative

The patient could desaturate because of interrupted oxygen delivery.

Event Description

Defected bonded between the glasses and the tubing. .

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
• Type of Device: 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
• MDR Text Key: 315444392
• Report Number: 3000219639-2023-00012
• Device Sequence Number: 1
• Product Code: CAT
• UDI-Device Identifier: 10607411101110
• UDI-Public: 10607411101110
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1053-7-50
• Device Catalogue Number: 1053-7-50
• Device Lot Number: 10211213
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other