MAUDE Adverse Event Report: SALTER LABS PARKER; TRACH-VAC WITH FLEX-TIP, PVC CUFF & STYLET, PARKER, 7.0MM

Model Number	I-PFTVVCS-70-100
Medical Device Problem Codes	Leak/Splash (1354); Gas/Air Leak (2946)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The inflating tube was torn and a leak was observed from there.The patient was moved to icu when a gurgling sound was heard coming from the patients' mouth.The inflating tube was torn and a leak was observed from there.They checked the oral cavity and found that the sound was coming from the trachea.
Additional Manufacturer Narrative
All information reasonably known as of 02 july 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.
Event or Problem Description
The inflating tube was torn and a leak was observed from there.The patient was moved to icu when a gurgling sound was heard coming from the patients' mouth.The inflating tube was torn and a leak was observed from there.They checked the oral cavity and found that the sound was coming from the trachea.
Additional Manufacturer Narrative
All information reasonably known as of 02 july 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.Complaint was considered not confirmed based on customer narrative of events.It is unclear if there was a material failure or if the product failed due to patient movement.A 24 month review was conducted and 12 additional complaints were identified related to this issue however no trend was observed.No lot number was provided for further investigation, however the vendor was notified of the incident.This incident was not identified as an increasing trend.No further action to be taken.

• Brand Name: PARKER
• Common Device Name: TRACH-VAC WITH FLEX-TIP, PVC CUFF & STYLET, 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: 19658985
• Report Number: 3000219639-2024-00053
• Device Sequence Number: 15109339
• Product Code: BTR
• UDI-Device Identifier: 10749065191700
• UDI-Public: 10749065191700
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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: I-PFTVVCS-70-100
• Device Catalogue Number: I-PFTVVCS-70-100
• 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: 06/02/2024
• Supplement Date Received by Manufacturer: 06/02/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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: Required Intervention; Other
• Patient Sex: Unknown