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	2359	2365
Use of Device Problem	2028	2029
Material Split, Cut or Torn	527	527
Inflation Problem	414	418
Disconnection	347	348
Defective Component	319	321
Leak/Splash	264	267
Connection Problem	187	187
Deflation Problem	168	168
Material Puncture/Hole	116	116
Detachment of Device or Device Component	112	112
Material Integrity Problem	107	107
Material Twisted/Bent	98	98
Fluid/Blood Leak	85	85
Material Rupture	83	83
Unintended Deflation	80	80
Insufficient Information	77	77
Obstruction of Flow	76	76
Break	75	75
Device Markings/Labelling Problem	70	70
Appropriate Term/Code Not Available	67	68
Human-Device Interface Problem	59	60
Labelling, Instructions for Use or Training Problem	59	59
Crack	54	54
Separation Problem	50	50
Material Separation	42	42
Contamination /Decontamination Problem	40	40
Defective Device	36	36
Deformation Due to Compressive Stress	36	39
Mechanical Problem	36	36
Material Deformation	35	35
Burst Container or Vessel	32	32
Patient-Device Incompatibility	31	31
Material Too Rigid or Stiff	27	27
Component Missing	26	26
Loose or Intermittent Connection	23	23
Physical Resistance/Sticking	23	23
Pressure Problem	21	25
Decrease in Pressure	18	18
Failure to Deflate	18	18
Inadequacy of Device Shape and/or Size	17	17
Component Incompatible	17	17
Manufacturing, Packaging or Shipping Problem	17	17
Fitting Problem	16	16
Failure to Disconnect	16	16
Decoupling	16	16
Delivered as Unsterile Product	16	16
Tear, Rip or Hole in Device Packaging	15	15
Air/Gas in Device	15	15
Complete Blockage	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4647	4655
Unintended Extubation	1959	1962
Insufficient Information	996	1004
Low Oxygen Saturation	287	290
Hypoventilation	153	154
Unspecified Tissue Injury	82	82
Cardiac Arrest	80	81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	54	54
Hypoxia	50	50
Respiratory Insufficiency	35	35
Hemorrhage/Bleeding	35	35
Airway Obstruction	34	35
Decreased Respiratory Rate	32	32
Dyspnea	28	28
Aspiration/Inhalation	23	24
Swelling/ Edema	23	23
No Consequences Or Impact To Patient	22	22
Unspecified Respiratory Problem	21	21
Respiratory Failure	19	19
Respiratory Arrest	19	19
Pneumonia	18	18
Bradycardia	16	16
Pain	15	15
Foreign Body In Patient	14	14
Tachycardia	11	11
Discomfort	10	10
Low Blood Pressure/ Hypotension	9	9
No Information	9	9
Laceration(s)	8	8
Pneumothorax	8	8
Increased Respiratory Rate	7	7
Obstruction/Occlusion	6	6
Skin Inflammation/ Irritation	6	6
Ventilator Dependent	5	5
Wheezing	5	5
Adult Respiratory Distress Syndrome	5	5
No Patient Involvement	5	5
Pressure Sores	4	4
Sore Throat	4	4
Fever	4	4
Bronchospasm	4	4
High Blood Pressure/ Hypertension	4	4
Abrasion	3	3
Convulsion/Seizure	3	3
Ulcer	3	3
Pulmonary Emphysema	3	3
Forced Expiratory Volume Decreased	3	3
Vomiting	3	3
Apnea	3	3
Bronchitis	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