MAUDE Adverse Event Report: SALTER LABS SALTER LABS; AIR LEAKED FROM THE CONNECTOR OF THE CANNULA; IT PULLED APART EASILY WHEN TUGGED

Model Number	16SOFT-INF-7-50
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Air leaked from the connector of the cannula; it pulled apart easily when tugged gently.
Additional Manufacturer Narrative
If it was not noticed right away the patient could become hypoxia.
Additional Manufacturer Narrative
If it was not noticed right away the patient could become hypoxia.Complaint history reviewed.There has been 1 similar complaint in the previous 24 months for 16soft-inf cannula (cc-07061).Most likely root cause of issue is the bond between the tubing and wye deteriorated.This can occur for several reasons, such as: accelerated aging or improper storage/transit conditions, not enough bonding agent being applied during assembly, improper insertion depth of the tubing, or long-term use of the cannula.Storage and use conditions are noted on the ifu, and it is generally recommended that cannulas are replaced every 14 days.Previous corrective actions were implemented in early 2022.: visual aid 211 was updated, a quality alert was generated, the assembly and packaging area personnel were trained.An awareness talk was given to operational and quality personnel about senko's customer complaints in february 2022.(see cc#7360).Risk(rma-20017a): r101: low oxygen delivery - cannula tubing adhesive bonds deteriorate resulting in leaks prior to first use - s=8 o=1 rpn=8.Rpn < 25, therefore risk is acceptable.
Event or Problem Description
Air leaked from the connector of the cannula; it pulled apart easily when tugged gently.

• Brand Name: SALTER LABS
• Common Device Name: AIR LEAKED FROM THE CONNECTOR OF THE CANNULA; IT PULLED APART EASILY WHEN TUGGED
• 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: 17175392
• Report Number: 3000219639-2023-00019
• Device Sequence Number: 3534541
• Product Code: CAT
• UDI-Device Identifier: 10607411952606
• UDI-Public: 10607411952606
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/21/2023

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-INF-7-50
• Device Catalogue Number: 16SOFT-INF-7-50
• Device Lot Number: 21024,220130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/20/2023
• 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