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
1. K210516 Clicky Cross

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	1448	1458
Leak/Splash	441	442
Disconnection	292	292
Crack	256	256
No Flow	238	240
Break	173	175
Material Separation	146	146
Device Contamination with Chemical or Other Material	125	126
Air/Gas in Device	113	114
Separation Problem	54	54
Particulates	54	54
Loose or Intermittent Connection	54	54
Infusion or Flow Problem	51	51
Connection Problem	50	50
Detachment of Device or Device Component	43	43
Defective Component	39	41
Backflow	36	36
Contamination	30	30
Obstruction of Flow	27	27
Material Split, Cut or Torn	25	25
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
Insufficient Flow or Under Infusion	9	9
Separation Failure	8	8
Free or Unrestricted Flow	8	8
Inaccurate Delivery	7	7
Device Markings/Labelling Problem	7	7
Unsealed Device Packaging	7	7
Material Integrity Problem	7	7
Material Rupture	7	7
Delivered as Unsterile Product	7	7
Contamination /Decontamination Problem	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
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	2674	2679
No Consequences Or Impact To Patient	221	221
Insufficient Information	119	126
Chemical Exposure	111	111
Low Blood Pressure/ Hypotension	89	90
No Known Impact Or Consequence To Patient	63	65
Hemorrhage/Bleeding	61	61
No Patient Involvement	38	38
Hypoglycemia	10	10
Air Embolism	9	9
High Blood Pressure/ Hypertension	9	9
Blood Loss	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
Exposure to Body Fluids	5	5
Cardiac Arrest	5	5
Death	4	4
Ventricular Fibrillation	3	3
No Information	3	3
Discomfort	2	2
Emotional Changes	2	2
Hypersensitivity/Allergic reaction	2	2
Anxiety	2	2
Hypoxia	2	2
Bacterial Infection	2	2
Stroke/CVA	2	2
Loss of consciousness	2	2
Ventilator Dependent	2	2
Skin Burning Sensation	2	2
Blister	1	1
Embolism/Embolus	1	1
Overdose	1	1
Burning Sensation	1	1
Loss Of Pulse	1	1
Thrombosis/Thrombus	1	1
Malaise	1	1
Missed Dose	1	1
Cardiogenic Shock	1	1
Diaphoresis	1	1
Cardiopulmonary Arrest	1	1
Pain	1	1
Shaking/Tremors	1	1
Radiation Overdose	1	1
Underdose	1	1
Convulsion/Seizure	1	1
Patient Problem/Medical Problem	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