TPLC - Total Product Life Cycle

show TPLC since

Device	device, fixation, tracheal tube
Regulation Description	Tracheal tube fixation device.
Product Code	CBH
Regulation Number	868.5770
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	35	35
Break	30	30
Material Separation	23	23
Fracture	10	10
Insufficient Information	8	8
Appropriate Term/Code Not Available	7	7
Loss of or Failure to Bond	6	6
Device Dislodged or Dislocated	6	6
Separation Problem	5	5
Device Slipped	4	4
Detachment of Device or Device Component	4	4
Use of Device Problem	4	4
Device-Device Incompatibility	3	3
Material Split, Cut or Torn	3	3
Difficult to Open or Close	3	3
Patient Device Interaction Problem	3	3
Improper or Incorrect Procedure or Method	2	2
Material Deformation	2	2
Sharp Edges	2	2
Gas/Air Leak	2	2
Material Integrity Problem	2	2
Material Frayed	2	2
Disconnection	2	2
Material Too Rigid or Stiff	1	1
Stretched	1	1
Component Missing	1	1
Material Fragmentation	1	1
Material Twisted/Bent	1	1
Positioning Problem	1	1
Inflation Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Fell	1	1
Material Disintegration	1	1
No Apparent Adverse Event	1	1
Migration	1	1
Physical Resistance/Sticking	1	1
Malposition of Device	1	1
Mechanical Problem	1	1
Nonstandard Device	1	1
Inadequate or Insufficient Training	1	1
Connection Problem	1	1
Entrapment of Device	1	1
Premature Separation	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	46	46
Insufficient Information	28	28
No Consequences Or Impact To Patient	28	28
Tissue Breakdown	14	14
Pressure Sores	14	14
Hypoventilation	13	13
Extubate	9	9
No Known Impact Or Consequence To Patient	8	8
Unspecified Tissue Injury	5	5
Skin Tears	5	5
Cardiac Arrest	4	4
Skin Erosion	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Unintended Extubation	3	3
Airway Obstruction	2	2
Skin Discoloration	2	2
Rash	2	2
Injury	2	2
Laceration(s)	2	2
Unspecified Respiratory Problem	2	2
Ulcer	2	2
Aspiration Pneumonitis	1	1
Device Embedded In Tissue or Plaque	1	1
Respiratory Failure	1	1
Low Oxygen Saturation	1	1
Respiratory Insufficiency	1	1
Hemorrhage/Bleeding	1	1
Hypoxia	1	1
Fluid Discharge	1	1
Bradycardia	1	1
Choking	1	1
Fall	1	1
Pleural Effusion	1	1
Foreign Body In Patient	1	1
Atrial Fibrillation	1	1
Inflammation	1	1
Skin Inflammation/ Irritation	1	1
Respiratory Arrest	1	1
No Code Available	1	1
Respiratory Distress	1	1
Unspecified Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Hollister Incorporated	II	Feb-19-2025
2	MEDLINE INDUSTRIES, LP - Northfield	II	Dec-18-2024