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	151	151
Suction Problem	147	147
Gas/Air Leak	133	133
Break	116	116
Material Integrity Problem	79	79
Disconnection	68	68
Material Split, Cut or Torn	35	35
Use of Device Problem	29	29
Inflation Problem	19	19
Detachment of Device or Device Component	18	18
Crack	18	18
Fluid/Blood Leak	17	17
Physical Resistance/Sticking	17	17
Adverse Event Without Identified Device or Use Problem	16	16
Decrease in Suction	16	16
Obstruction of Flow	14	14
Leak/Splash	13	13
Connection Problem	13	13
Excess Flow or Over-Infusion	13	13
Loose or Intermittent Connection	11	11
Nonstandard Device	11	11
Material Separation	10	10
Unintended Deflation	10	10
Mechanical Problem	9	9
Complete Blockage	9	9
Increase in Suction	8	8
Defective Component	8	8
Material Twisted/Bent	7	7
Backflow	7	7
Defective Device	6	6
Difficult to Advance	6	6
Retraction Problem	5	5
Material Too Soft/Flexible	5	5
Difficult to Remove	4	4
Material Rupture	4	4
Device Damaged Prior to Use	4	4
Fracture	4	4
Failure to Advance	4	4
Device Dislodged or Dislocated	4	4
Malposition of Device	4	4
Component Missing	4	4
Inadequacy of Device Shape and/or Size	3	3
Incomplete or Inadequate Connection	3	3
Appropriate Term/Code Not Available	3	3
Infusion or Flow Problem	3	3
Difficult to Open or Remove Packaging Material	3	3
Material Puncture/Hole	3	3
Insufficient Information	3	3
Difficult to Insert	3	3
Material Fragmentation	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	429	429
Insufficient Information	252	252
No Consequences Or Impact To Patient	89	89
Low Oxygen Saturation	83	83
No Known Impact Or Consequence To Patient	33	33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	31	31
Foreign Body In Patient	26	26
Bacterial Infection	9	9
Respiratory Insufficiency	9	9
Bradycardia	9	9
Hypoventilation	8	8
Airway Obstruction	8	8
Hypoxia	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
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
Vomiting	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