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	2257	2263
Use of Device Problem	1928	1929
Material Split, Cut or Torn	513	513
Inflation Problem	404	408
Disconnection	341	342
Defective Component	319	321
Leak/Splash	259	262
Connection Problem	182	182
Deflation Problem	165	165
Material Puncture/Hole	112	112
Detachment of Device or Device Component	107	107
Material Integrity Problem	101	101
Material Twisted/Bent	98	98
Material Rupture	82	82
Fluid/Blood Leak	82	82
Unintended Deflation	79	79
Insufficient Information	77	77
Break	74	74
Obstruction of Flow	73	73
Device Markings/Labelling Problem	69	69
Appropriate Term/Code Not Available	64	65
Labelling, Instructions for Use or Training Problem	59	59
Human-Device Interface Problem	54	55
Crack	54	54
Separation Problem	49	49
Material Separation	41	41
Contamination /Decontamination Problem	40	40
Mechanical Problem	36	36
Deformation Due to Compressive Stress	36	39
Defective Device	33	33
Burst Container or Vessel	32	32
Patient-Device Incompatibility	31	31
Material Too Rigid or Stiff	27	27
Material Deformation	26	26
Component Missing	26	26
Physical Resistance/Sticking	23	23
Loose or Intermittent Connection	22	22
Decrease in Pressure	18	18
Pressure Problem	18	22
Component Incompatible	17	17
Manufacturing, Packaging or Shipping Problem	17	17
Inadequacy of Device Shape and/or Size	17	17
Failure to Deflate	16	16
Failure to Disconnect	16	16
Fitting Problem	16	16
Delivered as Unsterile Product	16	16
Decoupling	16	16
Tear, Rip or Hole in Device Packaging	15	15
Complete Blockage	14	14
Air/Gas in Device	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4459	4467
Unintended Extubation	1903	1906
Insufficient Information	974	982
Low Oxygen Saturation	279	282
Hypoventilation	146	147
Unspecified Tissue Injury	82	82
Cardiac Arrest	73	74
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	54	54
Hypoxia	50	50
Hemorrhage/Bleeding	35	35
Airway Obstruction	34	35
Decreased Respiratory Rate	32	32
Respiratory Insufficiency	32	32
Dyspnea	25	25
Swelling/ Edema	23	23
No Consequences Or Impact To Patient	22	22
Unspecified Respiratory Problem	21	21
Respiratory Failure	19	19
Pneumonia	18	18
Respiratory Arrest	17	17
Aspiration/Inhalation	17	18
Bradycardia	16	16
Pain	15	15
Foreign Body In Patient	14	14
Tachycardia	11	11
Discomfort	10	10
No Information	9	9
Pneumothorax	8	8
Low Blood Pressure/ Hypotension	8	8
Laceration(s)	8	8
Increased Respiratory Rate	7	7
Skin Inflammation/ Irritation	6	6
Obstruction/Occlusion	6	6
No Patient Involvement	5	5
Adult Respiratory Distress Syndrome	5	5
Wheezing	5	5
Ventilator Dependent	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
Sore Throat	3	3
Abrasion	3	3
Pulmonary Emphysema	3	3
Device Embedded In Tissue or Plaque	3	3
Bronchitis	3	3
Apnea	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