MAUDE Adverse Event Report: SALTER LABS SALTER LABS; BX10 - COMBO MILLER 3 DISPOSABLE BLADE ..W/ MEDIUM DISPOSABLE HANDLE

Model Number	1033.C2015.C
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Light is flickering.Possible delayed intubation.
Additional Manufacturer Narrative
Reportable possible delay in patient intubation and therapy.
Additional Manufacturer Narrative
Reportable possible delay in patient intubation and therapy.From initial email: product ref #404-7438 lot#s0520-038.Google search for "404-7438" "laryngoscope" found carnegie surgical website - which shows intubrite & sz 3 miller blade for sale under ref#404-7438.Carnegie surgical is not a distributor for sunmed products, most likely the customer has confused our products with another distributor.Sales team confirmed we do not sell product to cs, complaint does not fall in scope of complaint handling.If customer can prove use of a distributor that falls within scope of complaint system, complaint will be re-opened.Risk: product was not sold by an approved sunmed distributor, and most likely through a resaler or direct competitor.Therefore sunmed cannot directly or indirectly control quality of the product.No risk involved.
Event or Problem Description
Light is flickering.Possible delayed intubation.

• Brand Name: SALTER LABS
• Common Device Name: BX10 - COMBO MILLER 3 DISPOSABLE BLADE ..W/ MEDIUM DISPOSABLE HANDLE
• 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: 14645411
• Report Number: 3000219639-2022-00025
• Device Sequence Number: 4613447
• Product Code: CCW
• UDI-Device Identifier: 10607411966405
• UDI-Public: 10607411966405
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/09/2022

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: 1033.C2015.C
• Device Catalogue Number: 1033.C2015.C
• Device Lot Number: S0520-038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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