TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BRYAN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN, LLC
	SUBSTANTIALLY EQUIVALENT	3
FLEXICARE MEDICAL LIMITED.
	SUBSTANTIALLY EQUIVALENT	1
PIPELINE MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
WELL LEAD MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WILLIAM COOK EUROPE APS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	2205	2211
Use of Device Problem	1898	1899
Material Split, Cut or Torn	507	507
Inflation Problem	400	404
Disconnection	336	337
Defective Component	318	320
Leak/Splash	253	256
Connection Problem	180	180
Deflation Problem	161	161
Material Puncture/Hole	111	111
Detachment of Device or Device Component	106	106
Material Twisted/Bent	98	98
Material Integrity Problem	98	98
Fluid/Blood Leak	82	82
Material Rupture	81	81
Unintended Deflation	79	79
Insufficient Information	77	77
Break	74	74
Obstruction of Flow	73	73
Device Markings/Labelling Problem	67	67
Appropriate Term/Code Not Available	61	62
Labelling, Instructions for Use or Training Problem	59	59
Human-Device Interface Problem	54	55
Crack	53	53
Separation Problem	48	48
Material Separation	41	41
Contamination /Decontamination Problem	39	39
Mechanical Problem	36	36
Deformation Due to Compressive Stress	34	37
Defective Device	33	33
Burst Container or Vessel	32	32
Patient-Device Incompatibility	31	31
Material Too Rigid or Stiff	27	27
Component Missing	26	26
Material Deformation	25	25
Physical Resistance/Sticking	23	23
Loose or Intermittent Connection	22	22
Pressure Problem	18	22
Decrease in Pressure	17	17
Inadequacy of Device Shape and/or Size	17	17
Component Incompatible	17	17
Fitting Problem	16	16
Delivered as Unsterile Product	16	16
Failure to Disconnect	16	16
Failure to Deflate	16	16
Manufacturing, Packaging or Shipping Problem	15	15
Tear, Rip or Hole in Device Packaging	14	14
Complete Blockage	13	13
Gel Leak	13	14
Device Dislodged or Dislocated	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4383	4391
Unintended Extubation	1873	1876
Insufficient Information	961	969
Low Oxygen Saturation	275	278
Hypoventilation	141	142
Unspecified Tissue Injury	78	78
Cardiac Arrest	65	66
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	52	52
Hypoxia	49	49
Airway Obstruction	34	35
Decreased Respiratory Rate	32	32
Respiratory Insufficiency	32	32
Hemorrhage/Bleeding	32	32
Dyspnea	25	25
Swelling/ Edema	22	22
No Consequences Or Impact To Patient	22	22
Unspecified Respiratory Problem	18	18
Pneumonia	18	18
Respiratory Failure	18	18
Aspiration/Inhalation	17	18
Respiratory Arrest	16	16
Bradycardia	16	16
Pain	15	15
Foreign Body In Patient	13	13
Tachycardia	11	11
No Information	9	9
Discomfort	9	9
Low Blood Pressure/ Hypotension	8	8
Laceration(s)	8	8
Pneumothorax	7	7
Increased Respiratory Rate	7	7
Skin Inflammation/ Irritation	6	6
No Patient Involvement	5	5
Adult Respiratory Distress Syndrome	5	5
Wheezing	5	5
Ventilator Dependent	5	5
Obstruction/Occlusion	5	5
Fever	4	4
Bronchospasm	4	4
High Blood Pressure/ Hypertension	4	4
Vomiting	3	3
Pressure Sores	3	3
Ulcer	3	3
Convulsion/Seizure	3	3
Abrasion	3	3
Pulmonary Emphysema	3	3
Device Embedded In Tissue or Plaque	3	3
Bronchitis	3	3
Apnea	3	3
Unspecified Infection	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Covidien	II	Apr-01-2023
2	MEDLINE INDUSTRIES, LP - Northfield	I	May-28-2024
3	Smiths Medical ASD Inc.	II	Oct-27-2021
4	Smiths Medical ASD, Inc.	I	Mar-12-2025
5	TELEFLEX LLC	I	Jun-29-2023
6	TELEFLEX LLC	II	Jan-23-2023
7	Teleflex Medical Europe Ltd	II	Aug-19-2021