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	3
FLEXICARE MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
PIPELINE MEDICAL PRODUCTS, LLC
	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	2412	2417
Use of Device Problem	2016	2016
Material Split, Cut or Torn	533	533
Inflation Problem	431	434
Defective Component	359	359
Disconnection	315	315
Leak/Splash	299	301
Connection Problem	200	200
Deflation Problem	160	160
Material Puncture/Hole	120	120
Material Integrity Problem	116	116
Detachment of Device or Device Component	111	111
Material Twisted/Bent	108	108
Material Rupture	91	91
Obstruction of Flow	88	88
Break	83	83
Insufficient Information	82	82
Fluid/Blood Leak	81	81
Unintended Deflation	76	76
Appropriate Term/Code Not Available	69	69
Labelling, Instructions for Use or Training Problem	67	67
Crack	62	62
Material Separation	59	59
Device Markings/Labelling Problem	56	56
Human-Device Interface Problem	49	49
Separation Problem	46	46
Contamination /Decontamination Problem	46	46
Deformation Due to Compressive Stress	41	41
Mechanical Problem	41	41
Pressure Problem	40	44
Burst Container or Vessel	36	36
Defective Device	36	36
Material Deformation	32	32
Patient-Device Incompatibility	31	31
Physical Resistance/Sticking	26	26
Component Missing	25	25
Material Too Rigid or Stiff	25	25
Loose or Intermittent Connection	23	23
Inadequacy of Device Shape and/or Size	21	21
Component Incompatible	19	19
Decrease in Pressure	17	17
Fitting Problem	16	16
Failure to Disconnect	16	16
Failure to Deflate	16	16
Delivered as Unsterile Product	16	16
Partial Blockage	16	16
Tear, Rip or Hole in Device Packaging	16	16
Difficult to Remove	15	15
Fracture	14	14
Device Dislodged or Dislocated	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4161	4166
Unintended Extubation	1800	1800
Insufficient Information	927	932
Extubate	335	335
Low Oxygen Saturation	301	301
No Consequences Or Impact To Patient	292	292
No Patient Involvement	170	170
Hypoventilation	124	124
No Known Impact Or Consequence To Patient	82	82
Unspecified Tissue Injury	77	77
No Information	75	75
Hypoxia	63	63
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	49	49
Airway Obstruction	45	45
Cardiac Arrest	38	38
Hemorrhage/Bleeding	36	36
Decreased Respiratory Rate	33	33
Respiratory Insufficiency	33	33
Dyspnea	26	26
Swelling/ Edema	21	21
Respiratory Failure	19	19
Bradycardia	19	19
Unspecified Respiratory Problem	17	17
Pain	16	16
Respiratory Arrest	16	16
Pneumonia	15	15
Foreign Body In Patient	13	13
Aspiration/Inhalation	13	13
Pneumothorax	10	10
Death	10	10
Low Blood Pressure/ Hypotension	10	10
Obstruction/Occlusion	9	9
Discomfort	9	9
Injury	9	9
Tachycardia	8	8
Pulmonary Emphysema	7	7
Increased Respiratory Rate	7	7
Adult Respiratory Distress Syndrome	7	7
Skin Inflammation/ Irritation	6	6
Respiratory Distress	6	6
Laceration(s)	6	6
Wheezing	5	5
No Code Available	5	5
Ventilator Dependent	5	5
Bronchospasm	4	4
Device Embedded In Tissue or Plaque	4	4
Ulcer	3	3
Convulsion/Seizure	3	3
Pressure Sores	3	3
Vomiting	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