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

Model Number 6022.C

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2024

Event Type  malfunction  

Event Description

The fiber optic tube fixed to the blade became dislodged from the tip. .

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.

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 Description

The fiber optic tube fixed to the blade became dislodged from the tip. .

• Brand Name: SALTER LABS
• Type of Device: 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
• MDR Text Key: 337631069
• Report Number: 3000219639-2024-00024
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00607411964503
• UDI-Public: 00607411964503
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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