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 Problem	151	151
Suction Failure	151	151
Gas/Air Leak	141	141
Break	136	136
Material Integrity Problem	83	83
Disconnection	68	68
Material Split, Cut or Torn	45	45
Use of Device Problem	30	30
Mechanical Problem	21	21
Inflation Problem	19	19
Detachment of Device or Device Component	18	18
Crack	18	18
Fluid/Blood Leak	17	17
Decrease in Suction	17	17
Physical Resistance/Sticking	17	17
Adverse Event Without Identified Device or Use Problem	16	16
Obstruction of Flow	15	15
Leak/Splash	14	14
Excess Flow or Over-Infusion	14	14
Connection Problem	14	14
Nonstandard Device	12	12
Loose or Intermittent Connection	11	11
Material Separation	11	11
Unintended Deflation	10	10
Complete Blockage	9	9
Material Puncture/Hole	9	9
Material Twisted/Bent	8	8
Inadequacy of Device Shape and/or Size	8	8
Increase in Suction	8	8
Defective Component	8	8
Backflow	7	7
Defective Device	6	6
Difficult to Advance	6	6
Infusion or Flow Problem	6	6
Component Missing	5	5
Material Too Soft/Flexible	5	5
Retraction Problem	5	5
Difficult to Remove	4	4
Device Dislodged or Dislocated	4	4
Failure to Advance	4	4
Fracture	4	4
Malposition of Device	4	4
Material Rupture	4	4
Device Damaged Prior to Use	4	4
Tidal Volume Fluctuations	3	3
Contamination	3	3
Contamination /Decontamination Problem	3	3
Insufficient Information	3	3
Appropriate Term/Code Not Available	3	3
Patient Device Interaction Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	487	487
Insufficient Information	256	256
No Consequences Or Impact To Patient	89	89
Low Oxygen Saturation	86	86
No Known Impact Or Consequence To Patient	33	33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	32	32
Foreign Body In Patient	26	26
Respiratory Insufficiency	10	10
Bacterial Infection	9	9
Hypoxia	9	9
Bradycardia	9	9
Hypoventilation	8	8
Airway Obstruction	8	8
No Code Available	7	7
Discomfort	7	7
Decreased Peak Expiratory Flow rate	6	6
Unspecified Respiratory Problem	6	6
Cardiac Arrest	5	5
Respiratory Distress	4	4
Pneumonia	4	4
Unspecified Infection	3	3
Vomiting	3	3
Increased Respiratory Rate	3	3
Arrhythmia	2	2
Abdominal Distention	2	2
Aspiration/Inhalation	2	2
Choking	2	2
Tachycardia	2	2
Aspiration Pneumonitis	1	1
Distress	1	1
Unintended Extubation	1	1
Decreased Respiratory Rate	1	1
Ventilator Dependent	1	1
Hemorrhage/Bleeding	1	1
Pulmonary Valve Insufficiency/ Regurgitation	1	1
Headache	1	1
Extubate	1	1
Cough	1	1
Unspecified Kidney or Urinary Problem	1	1
Pain	1	1
Asphyxia	1	1
Respiratory Tract Infection	1	1
Chest Pain	1	1
No Patient Involvement	1	1
Intracranial Hemorrhage	1	1
Unspecified Nervous System Problem	1	1
Laceration(s) of Esophagus	1	1
Hematoma	1	1
Inflammation	1	1
No Information	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	Avanos Medical, Inc.	II	Jan-08-2020
6	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
7	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
8	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-29-2022
9	Medline Industries Inc	II	Oct-06-2020
10	Medline Industries Inc	II	Jul-28-2020
11	RESPIRATORY THERAPEUTICS GROUP LLC	II	Mar-05-2020