MAUDE Adverse Event Report: SALTER LABS SALTER LABS; BX10 - COMBO MILLER 2 DISPOSABLE BLADE..W/ MEDIUM DISPOSABLE HANDLE

Model Number 1032.C2015.C

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 04/18/2022

Event Type  malfunction  

Event Description

Blades failed during intubation.

Manufacturer Narrative

Reportable as it delays intubation of patient.

Manufacturer Narrative

Reportable as it delays intubation of patient.Complaint history reviewed.This is a trending issue that currently has corrective actions being implemented to resolve it.Product was returned and failure mode could not be replicated via testing, complaint can not be confirmed.Risk (rma-20002b): r8: reduced or no visualization - light source not functional - s=9, o=2, rpn=18.Rpn < 25 therefore risk is acceptable.Because corrective actions are already in place, carb review is unnecessary.

Event Description

Blades failed during intubation.

• Brand Name: SALTER LABS
• Type of Device: BX10 - COMBO MILLER 2 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: 14436515
• MDR Text Key: 296778274
• Report Number: 3000219639-2022-00024
• Device Sequence Number: 1
• Product Code: CCW
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

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: 1032.C2015.C
• Device Catalogue Number: 1032.C2015.C
• Device Lot Number: A0420ADMS.0420AML2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 04/18/2022
• Supplement Dates FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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