MAUDE Adverse Event Report: SALTER LABS PARKER FLEX-TIP; PARKER TRACH VAC WITH FLEX-TIP AND THINCUFF (H-PFTVPU), 7.5MM

Model Number	I-PFTVPU-75-100 (H-PFTVPU-75-100)
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that immediately after intubation, the inflation tube detached, and reintubation was performed using a new tube.There was no report of harm or injury as a result of this event.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation, and no photographic or videographic evidence was provided by the reporter.In the absence of visual documentation, the complaint could not be confirmed; furthermore, without a returned sample for functional evaluation, the root cause could not be determined.The device history record for lot 2501tvu0101l was reviewed, and confirmed that the product was manufactured according to specifications.All information reasonably known as of 06 feb 2026 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 holdings complaint database and identified as (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.

• Brand Name: PARKER FLEX-TIP
• Common Device Name: PARKER TRACH VAC WITH FLEX-TIP AND THINCUFF (H-PFTVPU), 7.5MM
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): WELL LEAD MEDICAL CO., LTD.; c-4 jinhu industrial estate,; hualong; panyu, guangzhou 51143 4; JA 511434
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 24283673
• Report Number: 3004748541-2026-00035
• Device Sequence Number: 8319064
• Product Code: BTR
• UDI-Device Identifier: 10749065101754
• UDI-Public: (01)10749065101754(10)2501TVU0101L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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-PFTVPU-75-100 (H-PFTVPU-75-100)
• Device Catalogue Number: I-PFTVPU-75-100 (H-PFTVPU-75-1
• Device Lot Number: 2501TVU0101L
• 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: 11/21/2025
• Initial Report FDA Received Date: 02/06/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown