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U.S. Department of Health and Human Services

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

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SALTER LABS SALTER LABS; BX20 - MAC 2 DISPOSABLE FIBEROPTIC BLADE Back to Search Results
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. .
 
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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 Key18804832
MDR Text Key337631069
Report Number3000219639-2024-00024
Device Sequence Number1
Product Code CCW
UDI-Device Identifier00607411964503
UDI-Public00607411964503
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Number6022.C
Device Catalogue Number6022.C
Device Lot Number253
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/30/2024
Initial Date FDA Received02/28/2024
Supplement Dates Manufacturer Received01/30/2024
Supplement Dates FDA Received04/18/2024
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 Number1
Patient Outcome(s) Other;
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