MAUDE Adverse Event Report: PARKER MEDICAL PARKER FLEX-TIP; ENDOTRACHEAL TUBE, REINFORCED, CUFFED (PFRC), PARKER, 8.0MM

Model Number	I-PFRCS-80
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation.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 08 jan 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.
Event or Problem Description
It was reported that three days after intubation, medical staff noted suction was not functioning smoothly.On (b)(6) 2025, an x-ray revealed the tube was kinked beyond the back teeth.The tube was removed, and re-intubation was not performed.There were no reports of therapy delay, harm, or injury resulting from this event.
Additional Manufacturer Narrative
Correction: b5 the returned product was evaluated by the distributor; however, the reported event could not be confirmed.Functional testing of the device indicated that the endotracheal tube was not kinked.A review of complaint history identified no additional complaints involving the same part number and similar issue within the past 24 months.No trends were identified at this time.Continued monitoring will remain in place to detect any emerging trends.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 06 mar 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 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.
Event or Problem Description
This event is considered non-reportable under 21 cfr part 803.The investigation confirmed that product "i pfrcs 80" is marketed exclusively outside of the united states.Additionally, there is no identical or equivalent version of this device that is legally marketed or distributed by airlife within the u.S.It was reported that three days after intubation, medical staff noted suction was not functioning smoothly.On (b)(6) 2025, an x-ray revealed the tube was kinked beyond the back teeth.The tube was removed, and re-intubation was not performed.There were no reports of therapy delay, harm, or injury resulting from this event.

• Brand Name: PARKER FLEX-TIP
• Common Device Name: ENDOTRACHEAL TUBE, REINFORCED, CUFFED (PFRC), PARKER, 8.0MM
• Manufacturer (Section D): PARKER MEDICAL; 9457 s. university blvd.; pmb 331; highlands ranch CO 80126
• 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: 24011551
• Report Number: 3004748541-2026-00001
• Device Sequence Number: 4888470
• Product Code: BTR
• UDI-Device Identifier: 50749065081801
• UDI-Public: (01)50749065081801
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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-PFRCS-80
• Device Catalogue Number: I-PFRCS-80
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/06/2026
• 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