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

Model Number	I-PFRP-80 (H-PFRC-80)
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, immediately after intubation an air leak occurred.The tube was removed and reintubation with a new tube was performed.There was no report of a delay in therapy, harm or injury as a result of this reported event.
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 23 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 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, immediately after intubation an air leak occurred.The tube was removed and reintubation with a new tube was performed.There was no report of a delay in therapy, harm or injury as a result of this reported event.
Additional Manufacturer Narrative
Correction: d9.Additional information-investigation completion: d4; h2; h6.Functional testing was performed on the returned product.Test results confirm there was a hole in the cuff.The reported issue is confirmed; however, the root cause could not be determined.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 may 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 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.

• Brand Name: PARKER FLEX-TIP
• Common Device Name: ENDOTRACHEAL TUBE, REINFORCED, CUFFED (PFRC), PARKER, 8.0MM
• Manufacturer (Section D): SALTER LABS; 30 spur dr; el paso, tx 79906 ; JA 79906
• 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: 24169057
• Report Number: 3004748541-2026-00015
• Device Sequence Number: 9111256
• Product Code: BTR
• UDI-Device Identifier: 10749065081803
• UDI-Public: (01)10749065081803
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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-PFRP-80 (H-PFRC-80)
• Device Catalogue Number: I-PFRP-80 (H-PFRC-80)
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2025
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 05/14/2026
• 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 Sex: Unknown