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	1542	1552
Leak/Splash	397	398
Disconnection	299	299
Crack	279	279
No Flow	246	248
Break	176	176
Material Separation	149	149
Air/Gas in Device	122	123
Device Contamination with Chemical or Other Material	100	101
Connection Problem	74	74
Separation Problem	60	60
Particulates	58	58
Loose or Intermittent Connection	47	47
Detachment of Device or Device Component	43	43
Backflow	39	39
Defective Component	38	38
Contamination	33	33
Infusion or Flow Problem	31	31
Obstruction of Flow	27	27
Material Split, Cut or Torn	26	26
Fracture	21	21
Complete Blockage	18	18
Fitting Problem	15	15
Difficult to Open or Close	15	15
Material Puncture/Hole	14	14
Material Integrity Problem	13	13
Contamination /Decontamination Problem	12	12
Packaging Problem	10	10
Physical Resistance/Sticking	10	10
Insufficient Flow or Under Infusion	10	10
Free or Unrestricted Flow	9	9
Material Deformation	8	8
Separation Failure	8	8
Component Missing	8	8
Material Rupture	7	7
Delivered as Unsterile Product	7	7
Defective Device	7	7
Unsealed Device Packaging	7	7
Device Markings/Labelling Problem	7	7
Incomplete or Inadequate Connection	7	7
Inaccurate Delivery	6	6
Material Twisted/Bent	6	6
Mechanical Jam	6	6
Failure to Infuse	5	5
Improper Flow or Infusion	5	5
Inaccurate Flow Rate	5	5
Excess Flow or Over-Infusion	5	5
Difficult to Remove	4	4
Mechanical Problem	4	4
Gas/Air Leak	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2963	2968
Insufficient Information	126	133
Low Blood Pressure/ Hypotension	101	102
Chemical Exposure	93	93
No Consequences Or Impact To Patient	71	71
Hemorrhage/Bleeding	69	69
Discomfort	11	11
Air Embolism	10	10
Awareness during Anaesthesia	10	10
High Blood Pressure/ Hypertension	9	9
Cardiac Arrest	8	8
Hypoglycemia	8	8
Irritability	6	6
Sepsis	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
Unspecified Infection	3	3
Bacterial Infection	3	3
Ventricular Fibrillation	3	3
Skin Burning Sensation	2	2
Ventilator Dependent	2	2
Loss of consciousness	2	2
Anxiety	2	2
Fluid Discharge	2	2
No Patient Involvement	2	2
Adult Respiratory Distress Syndrome	2	2
Hypersensitivity/Allergic reaction	2	2
Stroke/CVA	2	2
Hyperglycemia	1	1
Pain	1	1
Thrombosis/Thrombus	1	1
Burning Sensation	1	1
Blood Loss	1	1
Embolism/Embolus	1	1
Shock	1	1
Shaking/Tremors	1	1
Hypoxia	1	1
Convulsion/Seizure	1	1
Malaise	1	1
Hematoma	1	1
Diaphoresis	1	1
Emotional Changes	1	1
Respiratory Insufficiency	1	1
Weight Changes	1	1
Extreme Exhaustion	1	1
Unintended Radiation Exposure	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	Smiths Medical ASD Inc.	II	Oct-20-2021