MAUDE Adverse Event Report: SALTER LABS PARKER; ENDOTRACHEAL TUBE, DEHP-FREE, LOW PRESSURE, POLYURETHANE CUFF, NO MURPHY EYES

Model Number	H-PTCL-35 (I-PTCL-35)
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint product was not returned for evaluation; however, the reporter provided photographic evidence.Analysis of the photos confirmed the reported complaint.The root cause could not be determined.No other complaints were identified for the same or similar reported event.We will continue to monitor for 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 05 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 sunmed holdings llc.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 sunmed holdings llc.Sunmed holdings llc 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 sunmed 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 a sunmed holdings llc.Product was defective or caused serious injury.
Event or Problem Description
It was reported that a patient was intubated on (b)(6) 2025.The inflating tube broke on (b)(6) 2025 and the patient was reintubated.There were no delays in therapy, nor any harm or injury associated with this event.

• Brand Name: PARKER
• Common Device Name: ENDOTRACHEAL TUBE, DEHP-FREE, LOW PRESSURE, POLYURETHANE CUFF, NO MURPHY EYES
• 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: 23729108
• Report Number: 3004748541-2025-00126
• Device Sequence Number: 13419754
• Product Code: BTR
• UDI-Device Identifier: 00607411957604
• UDI-Public: (01)00607411957604
• 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
• Report Date (Section B): 12/05/2025

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-PTCL-35 (I-PTCL-35)
• Device Catalogue Number: H-PTCL-35 (I-PTCL-35)
• 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: 11/06/2025
• Initial Report FDA Received Date: 12/05/2025
• 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 Age: 12 MO
• Patient Sex: Female