MAUDE Adverse Event Report: SALTER LABS SALTER LABS; ENDO-BRONCH, STANDARD TIP, DOUBLE LUMEN TUBE, LEFT, 32 FR

Model Number	I-PSTDL-32
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cuff tear would cause deflation during intubation.The interruption in therapy caused the patient to be re-intubated.
Event or Problem Description
A cuff tear occured during intubation of a patient with a small mouth.Patient was extubated and re-intubated with a different tube. .
Event or Problem Description
A cuff tear occured during intubation of a patient with a small mouth.Patient was extubated and re-intubated with a different tube. .
Additional Manufacturer Narrative
The cuff tear would cause deflation during intubation.The interruption in therapy caused the patient to be re-intubated.The complaint of "a cuff tear occurred during intubation of a patient with a small mouth" regarding part i-pstdl-32 was not confirmed.The root cause was not determined.A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been no other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.

• Brand Name: SALTER LABS
• Common Device Name: ENDO-BRONCH, STANDARD TIP, DOUBLE LUMEN TUBE, LEFT, 32 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: 18804830
• Report Number: 3000219639-2024-00015
• Device Sequence Number: 12574864
• Product Code: BTS
• UDI-Device Identifier: 10749065851383
• UDI-Public: 10749065851383
• 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): 02/28/2024

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-32
• Device Catalogue Number: I-PSTDL-32
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 05/23/2024
• 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