MAUDE Adverse Event Report: SALTER LABS SALTER LABS; ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 7.0MM

Model Number	I-PFHV-70
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Tracheal tube was kinked and the suction tube stopped halfway, so the tracheal tube was removed and a new tracheal tube was inserted.
Additional Manufacturer Narrative
The kinked tube would cause loss of ventilation and suction tube being blocked.The interruption in therapy caused the patient to be re-intubated.
Additional Manufacturer Narrative
The kinked tube would cause loss of ventilation and suction tube being blocked.The interruption in therapy caused the patient to be re-intubated.The complaint reported for " i-pfhv-70" the complaint investigation was performed based on the content of the issue reported.The kink tube caused a delay in procedure, as a new tracheal tube had to be re-inserted.Photos were provided and confirmed for "trace of kink" in the tube.There were no reported lot number provided; therefore, an inventory analysis of the tube was unable to be conducted.Based on the photo images provided a possible root cause of the kink may have been due to handling of the tube prior to usage.A risk assessment was performed, and the ultimate risk was determined to be medium which requires reporting to the capa review board.One (1) complaint was reported within the 24 months for "kinked." however, there were seven (7) other complaints reported for part number i-pfhv-70 during the same timeframe; the seven (7) complaints were for hole/perforation found and leak." we will continue to monitor trends during our periodic complaint review meetings.
Event or Problem Description
Tracheal tube was kinked and the suction tube stopped halfway, so the tracheal tube was removed and a new tracheal tube was inserted.

• Brand Name: SALTER LABS
• Common Device Name: ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 7.0MM
• 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: 18909186
• Report Number: 3000219639-2024-00030
• Device Sequence Number: 7042790
• Product Code: BTR
• UDI-Device Identifier: 00607411952739
• UDI-Public: 00607411952739
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: I-PFHV-70
• Device Catalogue Number: I-PFHV-70
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 04/25/2024
• 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