MAUDE Adverse Event Report: WELL LEAD MEDICAL CO., LTD. PARKER FLEX-TIP; PARKER FLEX-TIP TRACHEAL TUBE WITH STYLET, HIGH VOLUME LOW PRESSURE, CUFFED

Model Number	I-PFST-80 (H-PFST-80)
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
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 in-progress.All information reasonably known as of 19 dec 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 (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.
Event or Problem Description
It was reported that eight days after intubation, the inflating tube detached, requiring reintubation.Three days later, the inflation tube of the second device also detached.There were no reports of therapy delay, harm, or injury resulting from this event.Sunmed holdings llc received a single report that referenced two different incidents, which were associated with separate units and involved different patients.This is the first of two reports.Refer to 3004748541-2025-00151 for the second report.
Additional Manufacturer Narrative
Correction; b5.The complaint product was returned to the distributor for evaluation, and the reported event was confirmed.Functional testing of the returned product inflating tube detached.The root cause could not be determined.A review of complaint history identified one additional complaint involving the same part and a similar issue within the 24 months preceding this reported event.No additional trends were identified at this time.Continued monitoring will remain in place to detect any emerging trends.The device history record for lot 2410st2950m was reviewed, and confirmed that the product was manufactured according to specifications.All information reasonably known as of 03 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 information known 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 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 21 cfr 803, in compliance with the medical device reporting requirement, and should not be considered to be an admission that an airlife product is defective, caused, or contributed to a serious injury.
Event or Problem Description
It was reported that eight days after intubation, the inflating tube detached, requiring reintubation.Three days later, the inflation tube of the second device also detached.There were no reports of therapy delay, harm, or injury resulting from this event.Airlife received a single report that referenced two different incidents, which were associated with separate units and involved different patients.This is the first of two reports refer to 3004748541-2025-00151 for the second report.

• Brand Name: PARKER FLEX-TIP
• Common Device Name: PARKER FLEX-TIP TRACHEAL TUBE WITH STYLET, HIGH VOLUME LOW PRESSURE, CUFFED
• Manufacturer (Section D): WELL LEAD MEDICAL CO., LTD.; c-4 jinhu industrial estate,; hualong; panyu, guangzhou 51143 4; JA 511434
• 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: 23857833
• Report Number: 3004748541-2025-00150
• Device Sequence Number: 14709956
• Product Code: BTR
• UDI-Device Identifier: 10749065801807
• UDI-Public: (01)10749065801807(10)2410ST2950M
• 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): 03/03/2026

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-PFST-80 (H-PFST-80)
• Device Catalogue Number: I-PFST-80 (H-PFST-80)
• Device Lot Number: 2410ST2950M
• 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
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/04/2026
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 86 KG