MAUDE Adverse Event Report: WELL LEAD MEDICAL CO PARKER FLEX-TIP; TRACH-VAC WITH FLEX-TIP, PVC CUFF & STYLET, PARKER, 7.0MM, BOX/10, CASE/100

Model Number	I-PFTVVCS-70-100
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, automatic cuff pressure gauge alarmed frequently and re-intubation was performed.After checking for leaks by dipping the cuff in water, a pinhole-sized hole was found in the cuff.It was additionally reported; an anchor fast was used during intubation.Position changed every 2-3 hours to left and right.The tube position was changed left or right with anchor fast in use.There was no reported injury.
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation.Photographic evidence provided; the complaint was considered confirmed based on customer narrative of events.A review of the device history record is not possible as no lot number was provided.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided all information reasonably known as of 01 aug 2025 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 sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings 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 sun med holdings llc.Product is defective or caused serious injury.

• Brand Name: PARKER FLEX-TIP
• Common Device Name: TRACH-VAC WITH FLEX-TIP, PVC CUFF & STYLET, PARKER, 7.0MM, BOX/10, CASE/100
• Manufacturer (Section D): WELL LEAD MEDICAL CO; c-4 jinhu industrial estate; hualong; panyu, guangzhou 51143 4; JA 511434
• Manufacturer (Section G): SALTER LABS; 30 spur dr; el paso TX
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 22691740
• Report Number: 3004748541-2025-00041
• Device Sequence Number: 18427723
• Product Code: BTR
• UDI-Device Identifier: 10749065191700
• UDI-Public: (01)10749065191700
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2025

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-70-100
• Device Catalogue Number: H-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: 07/02/2025
• Initial Report FDA Received Date: 08/01/2025
• 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