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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, emergency airway
Product CodeBWC
Regulation Number 868.5090
Device Class 2


Premarket Reviews
ManufacturerDecision
VBM MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
  1.  K200190  ScalpelCric

MDR Year MDR Reports MDR Events
2019 1 1
2021 1 1
2022 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
Break 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Unclear Information 1 1
Difficult to Insert 1 1
Component Missing 1 1
Failure to Advance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
No Known Impact Or Consequence To Patient 1 1
Cardiac Arrest 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1
Respiratory Insufficiency 1 1
Low Oxygen Saturation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Tytek Medical Inc I Feb-12-2020
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