MAUDE Adverse Event Report: SALTER LABS SALTER LABS; ADULT NASAL CANNULA WITH 25' 3-CHANNEL TUBE

Model Number 16SOFT-25-25

Device Problem Material Integrity Problem (2978)

Patient Problems Obstruction/Occlusion (2422); Unspecified Respiratory Problem (4464)

Event Date 09/26/2023

Event Type  malfunction  

Event Description

Tube was pinched/no air flowing.Patient having trouble breathing with the item.

Manufacturer Narrative

Due to the blockage that was found in the cannula the patient was having trouble breathing with the cannula.The tubing may have an occlusion likely occurring from the mek dipping bonding process.The cannula assembly is a manual operation with 6+ bonds.Low/no mek resulting in a disconnection does occasionally occur.This risk is identified and mitigated in the risk analysis.

Event Description

Tube was pinched/no air flowing.Patient having trouble breathing with the item.

Manufacturer Narrative

Due to the blockage that was found in the cannula the patient was having trouble breathing with the cannula.The tubing may have an occlusion likely occurring from the mek dipping bonding process.The cannula assembly is a manual operation with 6+ bonds.Low/no mek resulting in a disconnection does occasionally occur.This risk is identified and mitigated in the risk analysis.The complaint history was reviewed, there was a similar complaint from the same customer (b)(4).In the past 24 months there were 3 complaints related to this issue with the 16soft family.Further evaluation with the dhr review showed sampling plan showed no errors, no non conformances, final inspection also showed no errors.Without confirmation the most likely cause is that during the production of the lines the resin did not have enough time to rest/cool after being extruded, so when the device that was coiled up too tightly the kink that formed became permanent after cooling (ai-16soft-25).For risk assessment, in rma-20017a, line r30 for "tubing kinking" and "low oxygen delivery" accurately reflects the complaint.S=8, o=2, rpn=16, rc=1.Severity of 8 calls for an escalation to capa.

• Brand Name: SALTER LABS
• Type of Device: ADULT NASAL CANNULA WITH 25' 3-CHANNEL TUBE
• 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: 18165402
• MDR Text Key: 329090965
• Report Number: 3000219639-2023-00036
• Device Sequence Number: 1
• Product Code: CAT
• UDI-Device Identifier: 00607411915857
• UDI-Public: 00607411915857
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 16SOFT-25-25
• Device Catalogue Number: 16SOFT-25-25
• Device Lot Number: (10)210524
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2023
• 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