TPLC - Total Product Life Cycle

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Device	catheters, suction, tracheobronchial
Regulation Description	Tracheobronchial suction catheter.
Product Code	BSY
Regulation Number	868.6810
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Suction Failure	147	147
Break	143	143
Suction Problem	135	135
Gas/Air Leak	122	122
Material Integrity Problem	82	82
Material Split, Cut or Torn	45	45
Use of Device Problem	37	37
Mechanical Problem	21	21
Disconnection	20	20
Inflation Problem	20	20
Leak/Splash	18	18
Fluid/Blood Leak	17	17
Crack	15	15
Decrease in Suction	15	15
Connection Problem	15	15
Adverse Event Without Identified Device or Use Problem	15	15
Excess Flow or Over-Infusion	14	14
Physical Resistance/Sticking	13	13
Material Puncture/Hole	11	11
Obstruction of Flow	10	10
Unintended Deflation	10	10
Detachment of Device or Device Component	9	9
Loose or Intermittent Connection	9	9
Complete Blockage	9	9
Material Separation	8	8
Increase in Suction	8	8
Defective Component	7	7
Inadequacy of Device Shape and/or Size	7	7
Nonstandard Device	7	7
Backflow	7	7
Infusion or Flow Problem	7	7
Material Twisted/Bent	7	7
Material Too Soft/Flexible	5	5
Device Dislodged or Dislocated	4	4
Difficult to Insert	4	4
Fracture	4	4
Difficult to Remove	4	4
Component Missing	4	4
Failure to Advance	4	4
Material Rupture	4	4
Defective Device	4	4
Device Damaged Prior to Use	4	4
Difficult to Open or Remove Packaging Material	3	3
Difficult to Advance	3	3
Tidal Volume Fluctuations	3	3
Contamination	3	3
Patient Device Interaction Problem	3	3
Mechanical Jam	3	3
Insufficient Information	3	3
Appropriate Term/Code Not Available	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	518	518
Insufficient Information	256	256
Low Oxygen Saturation	85	85
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	32	32
Foreign Body In Patient	24	24
Respiratory Insufficiency	10	10
Bacterial Infection	9	9
Airway Obstruction	8	8
Hypoventilation	8	8
Bradycardia	7	7
Discomfort	7	7
Unspecified Respiratory Problem	6	6
Hypoxia	6	6
Decreased Peak Expiratory Flow rate	6	6
No Consequences Or Impact To Patient	5	5
Pneumonia	4	4
Cardiac Arrest	4	4
Vomiting	3	3
Unspecified Infection	3	3
Choking	2	2
Aspiration/Inhalation	2	2
Tachycardia	2	2
Increased Respiratory Rate	2	2
Arrhythmia	2	2
Unspecified Nervous System Problem	1	1
Intracranial Hemorrhage	1	1
Laceration(s) of Esophagus	1	1
Abdominal Distention	1	1
Respiratory Tract Infection	1	1
Pain	1	1
Unspecified Kidney or Urinary Problem	1	1
Hematoma	1	1
Cough	1	1
Respiratory Arrest	1	1
Brain Injury	1	1
Pneumothorax	1	1
Apnea	1	1
Hemorrhage/Bleeding	1	1
Pulmonary Valve Insufficiency/ Regurgitation	1	1
Hypovolemic Shock	1	1
Ventilator Dependent	1	1
Decreased Respiratory Rate	1	1
Unintended Extubation	1	1
Distress	1	1
Aspiration Pneumonitis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Avanos Medical, Inc.	I	Apr-16-2025
2	Avanos Medical, Inc.	II	Nov-21-2023
3	Avanos Medical, Inc.	I	Mar-13-2023
4	Avanos Medical, Inc.	II	Mar-31-2022
5	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
6	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
7	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-29-2022