MAUDE Adverse Event Report: SALTER LABS PARKER; PARKER FLEX-TIP TRACHEAL TUBE WITH STYLET, HIGH VOLUME LOW PRESSURE

Model Number	H-PFST-70 (I-PFST-70)
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
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 14 nov 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 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, caused or contributed to a serious injury.
Event or Problem Description
It was reported that immediately after intubation, an air leak occurred.The tube was removed, and the patient was reintubated with a new tube.There was no reported injury.
Event or Problem Description
It was reported that immediately after intubation, an air leak occurred.The tube was removed, and the patient was reintubated with a new tube.There was no reported injury.
Additional Manufacturer Narrative
The complaint product was returned to the distributor for evaluation, and the reported event was confirmed.Functional testing of the returned product identified a hole in the cuff.The root cause could not be determined.A review of complaint history identified five additional complaints 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.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 02 mar 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 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 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.

• Brand Name: PARKER
• Common Device Name: PARKER FLEX-TIP TRACHEAL TUBE WITH STYLET, HIGH VOLUME LOW PRESSURE
• 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: 23560518
• Report Number: 3004748541-2025-00119
• Device Sequence Number: 18675260
• Product Code: BTR
• UDI-Device Identifier: 00607411958014
• UDI-Public: (01)00607411958014
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984528
• 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): 03/02/2026

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: H-PFST-70 (I-PFST-70)
• Device Catalogue Number: H-PFST-70 (I-PFST-70)
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 03/02/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown