TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Obstruction of Flow	463	463
Device Contamination with Chemical or Other Material	312	312
Suction Problem	220	220
Leak/Splash	175	175
Break	128	128
Detachment of Device or Device Component	86	86
Material Separation	73	73
Fluid/Blood Leak	72	72
Adverse Event Without Identified Device or Use Problem	55	55
Material Integrity Problem	44	44
Device Contaminated During Manufacture or Shipping	37	37
Disconnection	34	34
Unraveled Material	34	34
Use of Device Problem	21	21
Material Deformation	21	21
Detachment Of Device Component	19	19
Decrease in Suction	19	19
No Flow	16	16
Activation Problem	16	16
Appropriate Term/Code Not Available	14	14
Difficult to Remove	14	14
Entrapment of Device	12	12
Contamination /Decontamination Problem	10	10
Suction Failure	10	10
Kinked	9	9
Gas/Air Leak	8	8
Fitting Problem	8	8
Material Frayed	8	8
Fracture	8	8
Packaging Problem	8	8
Device Damaged Prior to Use	8	8
Insufficient Information	8	8
Material Twisted/Bent	7	7
Device Operates Differently Than Expected	7	7
Crack	7	7
Component Missing	6	6
Defective Component	6	6
Delivered as Unsterile Product	6	6
Material Puncture/Hole	5	5
No Apparent Adverse Event	5	5
Loose or Intermittent Connection	5	5
Improper or Incorrect Procedure or Method	5	5
Hole In Material	5	5
Material Split, Cut or Torn	5	5
Physical Resistance/Sticking	4	4
Tear, Rip or Hole in Device Packaging	4	4
Defective Device	4	4
Material Too Rigid or Stiff	4	4
Component Falling	4	4
Material Fragmentation	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	784	784
No Consequences Or Impact To Patient	410	410
No Patient Involvement	344	344
No Known Impact Or Consequence To Patient	175	175
Insufficient Information	47	47
Foreign Body In Patient	44	44
Pneumothorax	38	38
No Code Available	34	34
No Information	27	27
Unspecified Infection	11	11
Not Applicable	11	11
Swelling	9	9
Hemorrhage/Bleeding	9	9
Pain	9	9
Death	6	6
Seroma	6	6
Failure to Anastomose	6	6
Air Embolism	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Internal Organ Perforation	5	5
Airway Obstruction	5	5
Injury	5	5
Hematoma	5	5
Inflammation	5	5
Bacterial Infection	5	5
Pneumonia	5	5
Bradycardia	5	5
Pleural Effusion	4	4
Laceration(s)	4	4
Cardiac Tamponade	4	4
Reaction	4	4
Device Embedded In Tissue or Plaque	4	4
Swelling/ Edema	3	3
Pulmonary Emphysema	3	3
Necrosis	3	3
Dyspnea	3	3
Low Oxygen Saturation	3	3
Fistula	3	3
Unspecified Tissue Injury	2	2
Loss of consciousness	2	2
Hemothorax	2	2
Respiratory Failure	2	2
Chest Pain	2	2
Cardiac Perforation	2	2
Cardiac Arrest	2	2
Obstruction/Occlusion	2	2
Respiratory Distress	2	2
Adult Respiratory Distress Syndrome	2	2
Wound Dehiscence	2	2
Impaired Healing	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health 200, LLC	I	Feb-16-2024
2	ConvaTec, Inc	II	Mar-21-2019
3	Cook Inc.	II	Nov-21-2019
4	Customed, Inc	II	Apr-14-2016
5	Customed, Inc	II	Sep-03-2015
6	Invuity, Inc.	II	Oct-03-2012
7	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
8	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
9	Merit Medical Systems, Inc.	II	Aug-12-2024
10	Santanello Surgical LLC	II	Aug-09-2019
11	Teleflex Medical	II	Feb-16-2019