MAUDE Adverse Event Report: SALTER LABS N/A; SALTER STYLE NASAL O2 CANNULA (ADULT), 4' (1.2 M) 0 TO 6 LPM, NON DEHP

Model Number	16SOFT-4
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The leaks or loose pipes at the y connector would interrupt the patient therapy, and the patient could become hypoxia.
Event or Problem Description
Cannulas are leaking.
Event or Problem Description
Cannulas are leaking.
Additional Manufacturer Narrative
The leaks or loose pipes at the y connector would interrupt the patient therapy, and the patient could become hypoxia.Complaint stated as all four cannulas 0556 (from lots 0326622j03 & 032022j03) and 16-soft-4 (from lots 524262 & 425262) had leaks.Complaint unconfirmed due to lack of photos and no returned inventory.There was no inventory of any of the lots.For the dhr reviews, there was no nonconformities or failed inspections.Scrap and parts were pulled indicating that visual inspections caught errors.In the last 24 months, there have been 2 related complaints for part 0556, and 3 related complaints for 16-soft-4.Risk(pfmeaassy001): step 120: qc carries out inspection - non-conforming material in visual specifications/ functional test failure - components out of visual spec/components out of dimensional spec, s=7 o=1 d=4 rpn=28.Root cause cannot be determined at this time, however, most likely root cause is little or no bonding agent applied to bonding location during assembly.
Additional Manufacturer Narrative
The leaks or loose pipes at the y connector would interrupt the patient therapy, and the patient could become hypoxia.Complaint stated as all four cannulas 0556 (from lots 0326622j03 & 032022j03) and 16-soft-4 (from lots 524262 & 425262) had leaks.Complaint unconfirmed due to lack of photos and no returned inventory.There was no inventory of any of the lots.For the dhr reviews, there was no nonconformities or failed inspections.Scrap and parts were pulled indicating that visual inspections caught errors.In the last 24 months, there have been (b)(4) related complaints for part 0556, and (b)(4) related complaints for 16-soft-4.Risk(pfmeaassy001): step 120: qc carries out inspection - non-conforming material in visual specifications/ functional test failure - components out of visual spec/components out of dimensional spec, s=7 o=1 d=4 rpn=28.Root cause cannot be determined at this time, however, most likely root cause is little or no bonding agent applied to bonding location during assembly.Udi related data quality updates only.
Event or Problem Description
Cannulas are leaking.

• Brand Name: N/A
• Common Device Name: SALTER STYLE NASAL O2 CANNULA (ADULT), 4' (1.2 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: 18196861
• Report Number: 3000219639-2023-00038
• Device Sequence Number: 6554119
• Product Code: CAT
• UDI-Device Identifier: 00607411915833
• UDI-Public: (01)00607411915833(10)524262,(01)0060741195833(10)425262
• 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,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 16SOFT-4
• Device Catalogue Number: 16SOFT-4
• Device Lot Number: 524262, 425262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 10/24/2023; 10/24/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/15/2024; 07/23/2024
• 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