MAUDE Adverse Event Report: SALTER LABS SALTER LABS; ENDO-BRONCH, STANDARD TIP, DOUBLE LUMEN TUBE, LEFT, 35 FR

Model Number I-PSTDL-35

Device Problem Leak/Splash (1354)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 02/13/2023

Event Type  malfunction  

Manufacturer Narrative

Reportable, as they would have had to re-intubate.

Event Description

Air was leaking from the endotracheal adapter. after a few minutes of use, the patient was reintubated because of a leak from a portion of the endotracheal adapter.

Event Description

Air was leaking from the endotracheal adapter. after a few minutes of use, the patient was reintubated because of a leak from a portion of the endotracheal adapter.

Manufacturer Narrative

Reportable, as they would have had to re-intubate.Complaint confirmed with customer photo.Received root cause investigation from well lead, they could not determine the root cause.Performed risk analysis with rma-20024b and determined a severity rating of 6.Reviewed complaint history for 24 months preceding the complaint reporting; 3 complaints were found for this part.There is no trending.Sent resolution to the customer.

• Brand Name: SALTER LABS
• Type of Device: ENDO-BRONCH, STANDARD TIP, DOUBLE LUMEN TUBE, LEFT, 35 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 ledge, MI 49544 ; 6162598415
• MDR Report Key: 16537517
• MDR Text Key: 311234872
• Report Number: 3000219639-2023-00008
• Device Sequence Number: 1
• Product Code: CBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I-PSTDL-35
• Device Catalogue Number: I-PSTDL-35
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other