TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BRYAN MEDICAL , INC.
	SUBSTANTIALLY EQUIVALENT	1
BRYAN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN LLC
	SUBSTANTIALLY EQUIVALENT	1
FLEXICARE MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SALTER LABS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
VENNER MEDICAL (SINGAPORE) PTE LTD
	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	2264	2264
Use of Device Problem	1844	1844
Material Split, Cut or Torn	498	498
Inflation Problem	419	419
Defective Component	340	340
Disconnection	293	293
Leak/Splash	259	259
Connection Problem	190	190
Deflation Problem	149	149
Material Puncture/Hole	114	114
Material Integrity Problem	108	108
Detachment of Device or Device Component	107	107
Material Twisted/Bent	101	101
Material Rupture	86	86
Obstruction of Flow	82	82
Break	77	77
Insufficient Information	75	75
Unintended Deflation	72	72
Labelling, Instructions for Use or Training Problem	66	66
Fluid/Blood Leak	66	66
Appropriate Term/Code Not Available	63	63
Material Separation	58	58
Crack	54	54
Device Markings/Labelling Problem	52	52
Human-Device Interface Problem	47	47
Separation Problem	46	46
Contamination /Decontamination Problem	43	43
Deformation Due to Compressive Stress	41	41
Mechanical Problem	40	40
Pressure Problem	35	35
Defective Device	33	33
Material Deformation	30	30
Patient-Device Incompatibility	30	30
Physical Resistance/Sticking	25	25
Component Missing	25	25
Material Too Rigid or Stiff	23	23
Loose or Intermittent Connection	20	20
Component Incompatible	19	19
Inadequacy of Device Shape and/or Size	18	18
Decrease in Pressure	17	17
Tear, Rip or Hole in Device Packaging	16	16
Failure to Disconnect	16	16
Delivered as Unsterile Product	16	16
Burst Container or Vessel	16	16
Partial Blockage	15	15
Fitting Problem	15	15
Failure to Deflate	15	15
Fracture	14	14
Manufacturing, Packaging or Shipping Problem	14	14
Difficult to Remove	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3783	3783
Unintended Extubation	1704	1704
Insufficient Information	863	863
Extubate	335	335
No Consequences Or Impact To Patient	292	292
Low Oxygen Saturation	290	290
No Patient Involvement	170	170
Hypoventilation	105	105
No Known Impact Or Consequence To Patient	82	82
No Information	75	75
Unspecified Tissue Injury	72	72
Hypoxia	63	63
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	44	44
Airway Obstruction	44	44
Cardiac Arrest	37	37
Hemorrhage/Bleeding	35	35
Decreased Respiratory Rate	33	33
Respiratory Insufficiency	32	32
Dyspnea	24	24
Swelling/ Edema	21	21
Unspecified Respiratory Problem	18	18
Respiratory Failure	18	18
Bradycardia	17	17
Respiratory Arrest	16	16
Pain	16	16
Pneumonia	14	14
Foreign Body In Patient	13	13
Aspiration/Inhalation	12	12
Pneumothorax	10	10
Death	10	10
Low Blood Pressure/ Hypotension	9	9
Obstruction/Occlusion	9	9
Injury	9	9
Adult Respiratory Distress Syndrome	7	7
Increased Respiratory Rate	7	7
Pulmonary Emphysema	7	7
Tachycardia	7	7
Discomfort	7	7
Respiratory Distress	6	6
No Code Available	5	5
Wheezing	5	5
Laceration(s)	5	5
Ventilator Dependent	5	5
Bronchospasm	4	4
Device Embedded In Tissue or Plaque	4	4
Ulcer	3	3
Convulsion/Seizure	3	3
Vomiting	3	3
Swelling	3	3
Bronchitis	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Covidien	II	Apr-01-2023
2	Flexicare Medical Ltd.	I	Nov-26-2020
3	MEDLINE INDUSTRIES, LP - Northfield	I	May-28-2024
4	Smiths Medical ASD Inc.	II	Oct-27-2021
5	Smiths Medical ASD, Inc.	I	Mar-12-2025
6	TELEFLEX LLC	I	Jun-29-2023
7	TELEFLEX LLC	II	Jan-23-2023
8	TELEFLEX MEDICAL INC	II	Jul-10-2020
9	Teleflex Medical Europe Ltd	II	Aug-19-2021