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

Model Number	H-PFHV-70
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tracheal cuff would not hold pressure during intubation.This would cause an interruption in patient therapy delaying intubation.
Event or Problem Description
Cracked cuff valve."this incident occurred last weekend.It was reported to me that the endotracheal tube cuff was not holding pressure.The patient was subsequently re- intubated with a different tube (same size and lot#) and the second cuff was again, not holding pressure.After examining the valve on both tubes it was noted that either the valve or pilot balloon were cracked.The anesthetist inflated the balloon and occluded the pilot line to keep the cuff inflated.This was a very unusual occurrence.I was not present, but assume it was rather a manufacturing defect than damage from handling." has occurred multiple times and twice on one patient.Tubes tested fine but failed on patient.
Additional Manufacturer Narrative
The tracheal cuff would not hold pressure during intubation.This would cause an interruption in patient therapy delaying intubation.The complaint of "cuff not holding pressure."regarding part h-pfhv-70 was not confirmed.The root cause was not determined.A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been no other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
Cracked cuff valve."this incident occurred last weekend.It was reported to me that the endotracheal tube cuff was not holding pressure.The patient was subsequently re- intubated with a different tube (same size and lot#) and the second cuff was again, not holding pressure.After examining the valve on both tubes it was noted that either the valve or pilot balloon were cracked.The anesthetist inflated the balloon and occluded the pilot line to keep the cuff inflated.This was a very unusual occurrence.I was not present, but assume it was rather a manufacturing defect than damage from handling." has occurred multiple times and twice on one patient.Tubes tested fine but failed on patient.

• 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: 19007057
• Report Number: 3000219639-2024-00033
• Device Sequence Number: 21175346
• Product Code: BTR
• UDI-Device Identifier: 00607411952739
• UDI-Public: 00607411952739
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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: H-PFHV-70
• Device Catalogue Number: H=PFHV-70
• Device Lot Number: 2301HV0214K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/30/2024
• 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