TPLC - Total Product Life Cycle

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Device	stopcock, i.v. set
Regulation Description	Intravascular administration set.
Product Code	FMG
Regulation Number	880.5440
Device Class	2

Premarket Reviews
Manufacturer	Decision
BAXTER HEALTHCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ELCAM MEDICAL ACAL
	SUBSTANTIALLY EQUIVALENT	1
M/S ROMSONS INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
MEDEX
	SUBSTANTIALLY EQUIVALENT	1
YOMURA TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	1410	1420
Leak/Splash	438	439
Disconnection	289	289
Crack	251	251
No Flow	237	239
Break	172	174
Material Separation	145	145
Device Contamination with Chemical or Other Material	125	126
Air/Gas in Device	110	111
Loose or Intermittent Connection	54	54
Separation Problem	53	53
Particulates	53	53
Infusion or Flow Problem	51	51
Connection Problem	49	49
Detachment of Device or Device Component	43	43
Defective Component	39	41
Backflow	36	36
Obstruction of Flow	25	25
Contamination	25	25
Material Split, Cut or Torn	23	23
Complete Blockage	21	21
Fracture	19	19
Difficult to Open or Close	15	15
Fitting Problem	15	15
Packaging Problem	14	14
Material Puncture/Hole	11	11
Physical Resistance/Sticking	10	10
Excess Flow or Over-Infusion	10	10
Incomplete or Inadequate Connection	9	9
Material Deformation	9	9
Separation Failure	8	8
Free or Unrestricted Flow	8	8
Insufficient Flow or Under Infusion	8	8
Inaccurate Delivery	7	7
Device Markings/Labelling Problem	7	7
Unsealed Device Packaging	7	7
Delivered as Unsterile Product	7	7
Component Missing	7	7
Material Twisted/Bent	7	7
Defective Device	6	6
Mechanical Jam	6	6
Gas/Air Leak	6	6
Failure to Infuse	5	5
Material Integrity Problem	5	5
Material Rupture	5	5
Contamination /Decontamination Problem	5	5
Mechanical Problem	5	5
Inaccurate Flow Rate	5	5
Difficult to Remove	4	4
Improper Flow or Infusion	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2619	2624
No Consequences Or Impact To Patient	221	221
Insufficient Information	119	126
Chemical Exposure	110	110
Low Blood Pressure/ Hypotension	87	88
No Known Impact Or Consequence To Patient	63	65
Hemorrhage/Bleeding	57	57
No Patient Involvement	38	38
Air Embolism	9	9
High Blood Pressure/ Hypertension	9	9
Blood Loss	8	8
Hypoglycemia	8	8
Sepsis	7	7
Awareness during Anaesthesia	7	7
Irritability	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Low Oxygen Saturation	5	5
Tachycardia	5	5
Cardiac Arrest	5	5
Death	4	4
Exposure to Body Fluids	4	4
No Information	3	3
Ventricular Fibrillation	3	3
Skin Burning Sensation	2	2
Ventilator Dependent	2	2
Bacterial Infection	2	2
Loss of consciousness	2	2
Hypoxia	2	2
Anxiety	2	2
Discomfort	2	2
Emotional Changes	2	2
Hypersensitivity/Allergic reaction	2	2
Stroke/CVA	2	2
Cardiogenic Shock	1	1
Thrombosis/Thrombus	1	1
Cardiopulmonary Arrest	1	1
Burning Sensation	1	1
Pain	1	1
Loss Of Pulse	1	1
Overdose	1	1
Shaking/Tremors	1	1
Blister	1	1
Underdose	1	1
Radiation Overdose	1	1
Embolism/Embolus	1	1
Convulsion/Seizure	1	1
Malaise	1	1
Infiltration into Tissue	1	1
Missed Dose	1	1
Diaphoresis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	B Braun Medical Inc	II	Nov-26-2025
2	BD SWITZERLAND SARL	II	Apr-02-2025
3	Baxter Healthcare Corporation	II	Oct-16-2025
4	Becton Dickinson & Company	II	Jul-21-2022
5	ICU Medical, Inc.	I	Oct-23-2025
6	ICU Medical, Inc.	II	Sep-09-2022
7	ICU Medical, Inc.	II	Feb-05-2021
8	ICU Medical, Inc.	II	Dec-01-2020
9	ICU Medical, Inc.	II	May-06-2020
10	Smiths Medical ASD Inc.	II	Oct-20-2021