MAUDE Adverse Event Report: SALTER LABS N/A; SALTER STYLE NASAL O2 CANNULA (ADULT), 25' (7.6 M) 0 TO 6 LPM, NON DEHP

Model Number	16SOFT-25-25
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Unspecified Respiratory Problem (4464)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Tube was pinched/no air flowing.Patient having trouble breathing with the item.
Additional 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 or Problem Description
Tube was pinched/no air flowing.Patient having trouble breathing with the item.
Additional 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.
Event or Problem Description
Tube was pinched/no air flowing.Patient having trouble breathing with the item.
Additional 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.**udi related data quality updates only**.

• Brand Name: N/A
• Common Device Name: SALTER STYLE NASAL O2 CANNULA (ADULT), 25' (7.6 M) 0 TO 6 LPM, NON DEHP
• 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
• Report Number: 3000219639-2023-00036
• Device Sequence Number: 20494746
• Product Code: CAT
• UDI-Device Identifier: 10607411915854
• UDI-Public: (01)10607411915854(10)210524
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2024

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 09/26/2023; 09/26/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 12/14/2023; 07/23/2024
• 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