TPLC - Total Product Life Cycle

show TPLC since

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
SALTER LABS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
VENNER MEDICAL (SINGAPORE) PTE LTD
	SUBSTANTIALLY EQUIVALENT	1
WELL LEAD MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	2057	2057
Use of Device Problem	1669	1669
Material Split, Cut or Torn	450	450
Inflation Problem	393	393
Defective Component	325	325
Disconnection	246	246
Leak/Splash	244	244
Connection Problem	183	183
Deflation Problem	138	138
Detachment of Device or Device Component	107	107
Material Integrity Problem	103	103
Material Puncture/Hole	99	99
Material Twisted/Bent	87	87
Obstruction of Flow	74	74
Material Rupture	72	72
Break	70	70
Insufficient Information	67	67
Unintended Deflation	67	67
Labelling, Instructions for Use or Training Problem	66	66
Appropriate Term/Code Not Available	59	59
Fluid/Blood Leak	58	58
Material Separation	56	56
Crack	47	47
Separation Problem	46	46
Contamination /Decontamination Problem	42	42
Mechanical Problem	40	40
Deformation Due to Compressive Stress	40	40
Device Markings/Labelling Problem	37	37
Human-Device Interface Problem	35	35
Pressure Problem	35	35
Defective Device	32	32
Patient-Device Incompatibility	30	30
Material Deformation	29	29
Physical Resistance/Sticking	24	24
Component Missing	22	22
Component Incompatible	19	19
Material Too Rigid or Stiff	17	17
Loose or Intermittent Connection	17	17
Inadequacy of Device Shape and/or Size	17	17
Delivered as Unsterile Product	16	16
Failure to Disconnect	16	16
Fitting Problem	15	15
Decrease in Pressure	14	14
Partial Blockage	14	14
Difficult to Remove	14	14
Tear, Rip or Hole in Device Packaging	14	14
Fracture	14	14
Manufacturing, Packaging or Shipping Problem	13	13
Gel Leak	13	13
Burst Container or Vessel	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3372	3372
Unintended Extubation	1529	1529
Insufficient Information	787	787
Extubate	335	335
No Consequences Or Impact To Patient	292	292
Low Oxygen Saturation	264	264
No Patient Involvement	170	170
Hypoventilation	92	92
No Known Impact Or Consequence To Patient	82	82
No Information	75	75
Unspecified Tissue Injury	67	67
Hypoxia	59	59
Airway Obstruction	44	44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	42	42
Cardiac Arrest	37	37
Decreased Respiratory Rate	33	33
Hemorrhage/Bleeding	33	33
Respiratory Insufficiency	32	32
Dyspnea	21	21
Swelling/ Edema	19	19
Unspecified Respiratory Problem	17	17
Respiratory Failure	17	17
Respiratory Arrest	16	16
Bradycardia	16	16
Pneumonia	14	14
Pain	12	12
Foreign Body In Patient	12	12
Aspiration/Inhalation	11	11
Pneumothorax	10	10
Death	10	10
Obstruction/Occlusion	9	9
Low Blood Pressure/ Hypotension	9	9
Injury	9	9
Pulmonary Emphysema	7	7
Increased Respiratory Rate	7	7
Respiratory Distress	6	6
Tachycardia	6	6
Discomfort	6	6
Wheezing	5	5
No Code Available	5	5
Ventilator Dependent	5	5
Adult Respiratory Distress Syndrome	4	4
Device Embedded In Tissue or Plaque	4	4
Ulcer	3	3
Bronchospasm	3	3
Laceration(s)	3	3
Bronchitis	3	3
Vomiting	3	3
Swelling	3	3
High Blood Pressure/ Hypertension	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