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

Model Number 1033.C2015.C

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 05/10/2022

Event Type  malfunction  

Event Description

Light is flickering.Possible delayed intubation.

Manufacturer Narrative

Reportable possible delay in patient intubation and therapy.

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 Description

Light is flickering.Possible delayed intubation.

• Brand Name: SALTER LABS
• Type of Device: 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
• MDR Text Key: 296778449
• Report Number: 3000219639-2022-00025
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 10607411966405
• UDI-Public: 10607411966405
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 06/23/2022
• 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