TPLC - Total Product Life Cycle

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Device	adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Regulation Description	Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Product Code	DTL
Regulation Number	870.4290
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	328	328
Loose or Intermittent Connection	137	137
Human-Device Interface Problem	123	123
Air/Gas in Device	59	59
Fluid/Blood Leak	30	30
Improper or Incorrect Procedure or Method	16	16
Display or Visual Feedback Problem	16	16
Contamination /Decontamination Problem	15	15
Physical Resistance/Sticking	14	14
Unstable	12	12
Defective Device	8	8
Connection Problem	8	8
Material Deformation	7	7
Inflation Problem	7	7
Fitting Problem	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Device-Device Incompatibility	6	6
Tear, Rip or Hole in Device Packaging	5	5
Break	5	5
Crack	4	4
No Apparent Adverse Event	3	3
Fracture	3	3
Device Difficult to Setup or Prepare	3	3
Product Quality Problem	3	3
Deflation Problem	3	3
Gas/Air Leak	3	3
Unsealed Device Packaging	2	2
Material Puncture/Hole	2	2
Difficult to Advance	2	2
Contamination	2	2
Device Contamination with Chemical or Other Material	2	2
Material Split, Cut or Torn	2	2
Noise, Audible	2	2
Material Separation	2	2
Difficult to Remove	1	1
Positioning Problem	1	1
Activation, Positioning or Separation Problem	1	1
Incomplete or Inadequate Connection	1	1
Device Contamination with Body Fluid	1	1
Insufficient Device Problem Information	1	1
Corroded	1	1
Positioning Failure	1	1
Detachment of Device or Device Component	1	1
Patient Device Interaction Problem	1	1
Damaged Thread	1	1
Separation Failure	1	1
Mechanical Problem	1	1
Blocked Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	723	723
Insufficient Information	24	24
Air Embolism	23	23
Hemorrhage/Blood Loss/Bleeding	11	11
Low Blood Pressure/ Hypotension	5	5
Non specific EKG/ECG Changes	3	3
Ventricular Fibrillation	3	3
Arrhythmia	2	2
Myocardial Infarction	2	2
No Consequences Or Impact To Patient	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Embolism/Embolus	2	2
Unspecified Infection	1	1
Sepsis	1	1
Fluid Discharge	1	1
Unspecified Tissue Injury	1	1
Cardiac Arrest	1	1
Ischemic Heart Disease	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	May-16-2023
2	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
3	Medline Industries Inc	II	Sep-24-2021
4	Medline Industries, LP	I	May-08-2026
5	Medline Industries, LP	I	Apr-07-2026
6	Merit Medical Systems, Inc.	II	Nov-17-2025
7	Merit Medical Systems, Inc.	II	Sep-11-2025
8	Merit Medical Systems, Inc.	II	Apr-11-2022