MAUDE Adverse Event Report: SALTER LABS SALTER LABS; BX20 - PEDIATRIC DISPOSABLE HANDLE 2/BATTERY

Model Number 2016.C

Device Problem Defective Device (2588)

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

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

The defect caused the patient to have a delay in the intubation procedure.There was no patient injury, this incident will be reported.One handle had very dim lighting and another had no light at all.The blades and handles were determined to be the issue for the delayed intubation in a critical situation.Low illumination may delay intubation's or increase the number of failed attempts.Standard practice is that a laryngoscope be checked for proper illumination prior intubation.Limited or no illumination could compromise intubation or first pass success rate.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.

Event Description

Last night they tried to use one and it was very difficult to snap together and when i tried it this morning the light did not work.I did grab another blade & handle to see which was defective and it was the handle.

Manufacturer Narrative

A formal investigation could not be performed without returned product.The most likely root cause of this failure is a 2-battery and spacer configuration rather than a 3-battery configuration.In feb-2020, the intubrite pediatric handles switched from 2-batteries to 3-batteries, in order to improve the shelf life and performance of the handles.Complaint history for this part number was reviewed for the last 24 months.No similar complaints have been reported and this issue does not appear to be trending, but will continue to be monitored.This is a known issue with other part numbers, and it is being tracked.Customer follow up was performed via email, explaining the most likely root cause, the ongoing improvement project pertaining to this issue, and the complaint history for this part number.Ra: this failure mode (r8) is identified on the risk analysis file (ra-44).The severity of harm for this failure mode is considered a moderate (4) risk and does not meet the threshold for carb review (8).

Event Description

Last night they tried to use one and it was very difficult to snap together and when i tried it this morning the light did not work.I did grab another blade & handle to see which was defective and it was the handle.

• Brand Name: SALTER LABS
• Type of Device: BX20 - PEDIATRIC DISPOSABLE HANDLE 2/BATTERY
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso 79906
• MDR Report Key: 11825965
• MDR Text Key: 250738988
• Report Number: 3000219639-2021-00011
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2016.C
• Device Catalogue Number: 2016.C
• Device Lot Number: 070519ADPS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other