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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device non-bronchoscopic bronchoalveolar lavage catheter
Definition To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.
Product CodeOYI
Regulation Number 868.6810
Device Class 1

MDR Year MDR Reports MDR Events
2019 7 7
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 7 7
Malposition of Device 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 7 7
Pneumothorax 1 1
Foreign Body In Patient 1 1
Respiratory Insufficiency 1 1
Bradycardia 1 1

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