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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device trap, sterile specimen
Product CodeBYZ
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2016 3 3
2019 1 1
2020 1 1
2021 1 1
2022 2 2
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Suction Problem 3 3
Leak/Splash 2 2
Compatibility Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
Disconnection 1 1
Entrapment of Device 1 1
Loose or Intermittent Connection 1 1
Particulates 1 1
Product Quality Problem 1 1
Component Missing 1 1
Failure to Advance 1 1
Connection Problem 1 1
Device Packaging Compromised 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Respiratory Insufficiency 1 1
Insufficient Information 1 1
Airway Obstruction 1 1
Bradycardia 1 1
Foreign Body Sensation in Eye 1 1
Muscle Weakness 1 1
Choking 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medline Industries Inc II May-13-2014
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