MAUDE Adverse Event Report: PARKER MEDICAL PARKER FLEX TIP; ENDOTRACHEAL TUBE, HIGH VOLUME/LOW PRESSURE (PFHV), CUFFED, PARKER

Model Number	H-PFHV-70
Medical Device Problem Codes	Connection Problem (2900); Gas/Air Leak (2946)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Type of Reportable Event	Death
Event or Problem Description
It was reported a leak occurred from the cuff during intubation of the patient with heart failure.The doctor performed basic life support and intubated the tube after the patient had gone into cardiopulmonary arrest.Once an alarm sounded that the circuit had been disconnected, but the alarm stopped when air was injected into the cuff.After the patient died, a computed tomography scan (ct) scan of the intubation revealed no abnormalities; upon returning to the intensive care unit (icu), it was confirmed that air was leaking from the cuff of the endotracheal tube.It was additionally reported, the hospital believed the patient died because she was not well to begin with.
Additional Manufacturer Narrative
The product involved in the report was returned to the vendor for evaluation; additionally, a photograph was provided.Based on the investigation performed by the vendor and review of the photograph the cuff was verified to be damaged; the complaint is considered confirmed.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: ENDOTRACHEAL TUBE, HIGH VOLUME/LOW PRESSURE (PFHV), CUFFED, PARKER
• Manufacturer (Section D): PARKER MEDICAL; 9457 s. university blvd; pmb 331; highlands ranch CO 80126
• Manufacturer (Section G): WELL LEAD MEDICAL CO; c-4 jinhu industrial estate; hualong; panyu, guangzhou 51143 4; JA 511434
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 22692865
• Report Number: 3000219639-2025-00053
• Device Sequence Number: 8306892
• Product Code: BTR
• UDI-Device Identifier: 10749065011701
• UDI-Public: (01)10749065011701
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H-PFHV-70
• Device Catalogue Number: H-PFHV-70
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 68 YR
• Patient Sex: Female