TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	110	110
Fluid/Blood Leak	43	43
Material Puncture/Hole	28	28
Burst Container or Vessel	27	28
Material Fragmentation	25	25
Inflation Problem	18	18
Component Misassembled	17	17
Material Rupture	15	15
Device Handling Problem	10	10
Material Split, Cut or Torn	6	6
Leak/Splash	6	6
Difficult to Remove	5	5
Gas/Air Leak	5	5
Material Twisted/Bent	5	5
Device Contaminated During Manufacture or Shipping	4	4
Contamination of Device Ingredient or Reagent	4	4
Difficult to Insert	4	4
Fracture	4	4
Break	3	4
Material Separation	3	3
Failure to Infuse	3	3
Expiration Date Error	3	3
Packaging Problem	3	3
Decrease in Pressure	2	2
Partial Blockage	2	2
Physical Resistance/Sticking	2	2
Illegible Information	1	1
Failure to Deflate	1	1
Accessory Incompatible	1	1
Crack	1	1
Disconnection	1	1
Nonstandard Device	1	1
Delivered as Unsterile Product	1	1
Inadequate or Insufficient Training	1	1
Use of Device Problem	1	1
Fitting Problem	1	1
Component Missing	1	1
Solder Joint Fracture	1	1
No Apparent Adverse Event	1	1
Material Deformation	1	2
Infusion or Flow Problem	1	1
Defective Device	1	1
Deformation Due to Compressive Stress	1	1
Difficult to Advance	1	1
Difficult to Open or Close	1	1
Difficult to Open or Remove Packaging Material	1	1
Device Contamination with Chemical or Other Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	183	184
Urinary Tract Infection	20	20
Fever	17	17
Sepsis	15	15
Obstruction/Occlusion	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Insufficient Information	11	12
Perforation	10	10
Pain	10	10
Hematuria	9	9
Exposure to Body Fluids	9	9
Hemorrhage/Bleeding	8	8
Anemia	8	8
Laceration(s)	7	7
Renal Failure	6	6
No Consequences Or Impact To Patient	5	5
Unspecified Tissue Injury	5	5
Septic Shock	5	5
No Patient Involvement	4	4
Foreign Body In Patient	4	4
Respiratory Failure	3	3
Unspecified Infection	3	3
Pseudoaneurysm	2	2
Pneumonia	2	2
Abscess	2	2
Pleural Effusion	2	2
Urinary Incontinence	2	2
Pneumothorax	2	2
Liver Damage/Dysfunction	2	2
Urinary Retention	1	1
Confusion/ Disorientation	1	1
Post Operative Wound Infection	1	1
Transient Ischemic Attack	1	1
Cardiac Arrest	1	1
Unspecified Kidney or Urinary Problem	1	1
Inflammation	1	1
Hematoma	1	1
Skin Inflammation/ Irritation	1	1
Tachycardia	1	1
Bowel Perforation	1	1
Swelling/ Edema	1	1
Bacterial Infection	1	1
Ascites	1	1
Respiratory Insufficiency	1	1
Hemothorax	1	1
Low Blood Pressure/ Hypotension	1	1
Hypovolemic Shock	1	1
Pulmonary Embolism	1	1
Abdominal Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Sep-05-2025
2	Coloplast Manufacturing US, LLC	II	Apr-02-2024