MAUDE Adverse Event Report: SALTER LABS PARKER; PARKER ENDO-BRONCH WITH STANDARD TIP (LEFT DOUBLE-LUMEN ENDOBRONCHIAL TUBE)

Model Number	I-PSTDL-32
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: during use in the operation room, air leakage occurred from the blue cuff; the patient was not reintubated.There was no reported injury.
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 17 sep 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.
Additional Manufacturer Narrative
Additional information-investigation completion the actual sample from the reported event was evaluated by the supplier.Visual examination of the device confirmed, a tear in tube lumen.The sample was tested, by placing the sample underwater, bubbles were seen forming inside the tracheal tube.Additionally, the supplier reviewed 3 retained samples, from lot 2412dl3687b; which were scrutinized based on appearance and function.Visual examination of three retained samples confirmed their integrity; functional testing confirmed the samples consistently inflated during a 12 hour time span; all samples complied with the requirements.Based on analysis of the returned sample, the reported event could be confirmed as reported; however, the root cause was undetermined.The device history record for lot 2412dl3687b was reviewed and the product was produced according to product specifications.All information reasonably known as of 11 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: during use in the operation room, air leakage occurred from the blue cuff; the patient was not reintubated.There was no reported injury.

• Brand Name: PARKER
• Common Device Name: PARKER ENDO-BRONCH WITH STANDARD TIP (LEFT DOUBLE-LUMEN ENDOBRONCHIAL TUBE)
• Manufacturer (Section D): SALTER LABS; 30 spur dr; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur dr; el paso TX 79906
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 23078590
• Report Number: 3000219639-2025-00058
• Device Sequence Number: 14639815
• Product Code: CBI
• UDI-Device Identifier: 00607411959479
• UDI-Public: (01)00607411959479(10)2412DL3687B
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: I-PSTDL-32
• Device Catalogue Number: I-PSTDL-32
• Device Lot Number: 2412DL3687B
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 12/11/2025
• 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