MAUDE Adverse Event Report: Salter Labs Parker Flex-Tip; Parker Trach Vac with Flex-Tip and PVC Cuff (H-PFTVVC), 8.0mm

Model Number	I-PFTVVCS-75-100 (H-PFTVVCS-75-100)
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury

• Brand Name: Parker Flex-Tip
• Common Device Name: Parker Trach Vac with Flex-Tip and PVC Cuff (H-PFTVVC), 8.0mm
• 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: 50600214
• Report Number: 3004748541-2026-00152
• Device Sequence Number: 10711581
• Product Code: BTR
• UDI-Device Identifier: 10749065191755
• UDI-Public: (01)10749065191755
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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-PFTVVCS-75-100 (H-PFTVVCS-75-100)
• Device Catalogue Number: I-PFTVVCS-75-100 (H-PFTVVCS-75
• 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
• Initial Report FDA Received Date: 09/04/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown