MAUDE Adverse Event Report: SALTER LABS SALTER LABS; BX20 - MAC 2 DISPOSABLE FIBEROPTIC BLADE

Model Number	6022.C
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The fiber optic tube fixed to the blade became dislodged from the tip. .
Additional Manufacturer Narrative
The fiber optic tube being dislodged from the tip could cause an obstruction.In addition, this would be a choking hazard to patient during intubation.
Additional Manufacturer Narrative
The fiber optic tube being dislodged from the tip could cause an obstruction.In addition, this would be a choking hazard to patient during intubation.The complaint of "the fiber optic tube fixed to the blade became dislodged from the tip" regarding part 6022.C was confirmed.The root cause was not determined but could possibly be a result of torsion, shear or tensile forces.A risk assessment was performed, and the ultimate risk was determined to be medium which does require reporting to the capa review board.There have been 0 other complaints regarding the same part and a similar issue within the 24 months preceding the reporting of this issue.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
The fiber optic tube fixed to the blade became dislodged from the tip. .

• Brand Name: SALTER LABS
• Common Device Name: BX20 - MAC 2 DISPOSABLE FIBEROPTIC BLADE
• 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: 18804832
• Report Number: 3000219639-2024-00024
• Device Sequence Number: 20645129
• Product Code: CCW
• UDI-Device Identifier: 00607411964503
• UDI-Public: 00607411964503
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6022.C
• Device Catalogue Number: 6022.C
• Device Lot Number: 253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 02/28/2024
• 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