MAUDE Adverse Event Report: SALTER LABS N/A; NASAL CANNULA (ADULT) SALTER STYLE WITH 7' (2.1 M) SUPPLY TUBE

Model Number	1600-7-50
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
"the nasal tip became separated from the tubes during the night.The telescope was installed new on sunday evening june 11 before bedtime and the incident occurred on the night of (b)(6).The batch number has not been preserved.No clinical consequences.".
Additional Manufacturer Narrative
The separation would interrupt therapy, and the patient could become hypoxia.
Additional Manufacturer Narrative
The separation would interrupt therapy, and the patient could become hypoxia.Complaint history reviewed.There has been 8 similar complaints for 1600 cannulas in the previous 24 months.Complaint was confirmed via pictures sent by customer.Further evaluation cannot be conducted without rm or lot#.Most likely root cause is poor mek bonding strength.
Event or Problem Description
"the nasal tip became separated from the tubes during the night.The telescope was installed new on sunday evening (b)(6) before bedtime and the incident occurred on the night of june (b)(6).The batch number has not been preserved.No clinical consequences.".
Additional Manufacturer Narrative
The separation would interrupt therapy, and the patient could become hypoxia.Complaint history reviewed.There have been 8 similar complaints for 1600 cannulas in the previous 24 months.Complaint was confirmed via pictures sent by customer.Further evaluation cannot be conducted without rm or lot#.Most likely root cause is poor mek bonding strength.Udi related data quality updates only.
Event or Problem Description
"the nasal tip became separated from the tubes during the night.The telescope was installed new on sunday evening on (b)(6) before bedtime and the incident occurred on the night on (b)(6).The batch number has not been preserved.No clinical consequences.".

• Brand Name: N/A
• Common Device Name: NASAL CANNULA (ADULT) SALTER STYLE WITH 7' (2.1 M) SUPPLY 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: 17978264
• Report Number: 3000219639-2023-00029
• Device Sequence Number: 2504791
• Product Code: CAT
• UDI-Device Identifier: 10607411100250
• UDI-Public: (01)10607411100250
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1600-7-50
• Device Catalogue Number: 1600-7-50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 09/22/2023; 09/22/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/30/2023; 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