MAUDE Adverse Event Report: SALTER LABS SALTER LABS; ENDO-BRONCH, STANDARD TIP, DOUBLE LUMEN TUBE, LEFT, 37 FR

Model Number	I-PSTDL-37
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The scratches on the tracheal cuff and leak would cause the cuff to deflate.This would cause the pressure to decrease and prevent patient from being ventilated.The interruption in therapy caused the patient to be re-intubated.
Event or Problem Description
Multiple scratches were found on the tracheal cuff. after checking cuff pressure, tube was intubated into the patient, and the patient was immediately extubated because he was unable to ventilate.
Additional Manufacturer Narrative
The scratches on the tracheal cuff and leak would cause the cuff to deflate.This would cause the pressure to decrease and prevent patient from being ventilated.The interruption in therapy caused the patient to be re-intubated complaint was considered confirmed based on visual evidence provided by customer.A 24 month review was conducted and 2 additional complaints were identified related to this issue however no trend was observed.The lot number was provided and the vendor completed an investigation of the incident.The vendor was unable to determine a root cause based on retained samples and a dhr investigation.This incident was not identified as an increasing trend.No further action to be taken.
Event or Problem Description
Multiple scratches were found on the tracheal cuff. after checking cuff pressure, tube was intubated into the patient, and the patient was immediately extubated because he was unable to ventilate.

• Brand Name: SALTER LABS
• Common Device Name: ENDO-BRONCH, STANDARD TIP, DOUBLE LUMEN TUBE, LEFT, 37 FR
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 19008105
• Report Number: 3000219639-2024-00031
• Device Sequence Number: 9383521
• Product Code: BTR
• UDI-Device Identifier: 00607411959493
• UDI-Public: 00607411959493
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: I-PSTDL-37
• Device Catalogue Number: I-PSTDL-37
• Device Lot Number: 2309DL2218D
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/18/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown