MAUDE Adverse Event Report: SALTER LABS SALTER LABS; TRACH-VAC WITH FLEX-TIP, PVC CUFF & STYLET, PARKER, 8.0MM

Model Number	I-PFTVVCS-80
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inflation balloon deflated during intubation.The interruption in therapy caused the patient to be re-intubated.
Event or Problem Description
The inflating cuff disconnected from the tracheal tube.The patient was extubated and re-intubated with a different trachael tube.
Additional Manufacturer Narrative
The inflation balloon deflated during intubation.The interruption in therapy caused the patient to be re-intubated.The complaint of " the inflating cuff disconnected from the tracheal tube." regarding part i-pftvvcs-80 was 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
The inflating cuff disconnected from the tracheal tube.The patient was extubated and re-intubated with a different trachael tube.

• Brand Name: SALTER LABS
• Common Device Name: TRACH-VAC WITH FLEX-TIP, PVC CUFF & STYLET, PARKER, 8.0MM
• 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: 18804831
• Report Number: 3000219639-2024-00014
• Device Sequence Number: 7248704
• Product Code: BTR
• UDI-Device Identifier: 10749065191809
• UDI-Public: 10749065191809
• 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): 02/28/2024

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: I-PFTVVCS-80
• Device Catalogue Number: I-PFTVVCS-80
• 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: 01/29/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 05/23/2024
• 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