TPLC - Total Product Life Cycle

• Device: sealant, polymerizing
• Product Code: NBE
• Device Class: 3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
5	11	3	5	3	7

MDR Year	MDR Reports	MDR Events
2020	27	27
2021	9	9
2022	12	12
2023	14	14
2024	24	24
2025	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	47	47
Break	27	27
Patient-Device Incompatibility	5	5
Crack	4	4
Device Handling Problem	2	2
Fluid/Blood Leak	2	2
Insufficient Information	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Shipping Damage or Problem	1	1
Obstruction of Flow	1	1
Material Twisted/Bent	1	1
Device Contamination with Chemical or Other Material	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	37	37
Injury	11	11
Hemorrhage/Bleeding	8	8
Pericardial Effusion	7	7
Unspecified Infection	5	5
No Consequences Or Impact To Patient	5	5
Cardiac Tamponade	4	4
Pseudoaneurysm	4	4
Inflammation	3	3
Thrombosis	3	3
Insufficient Information	3	3
Abscess	3	3
Aspiration Pneumonitis	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Post Operative Wound Infection	2	2
Fever	2	2
Bacterial Infection	2	2
Pneumothorax	1	1
Infarction, Cerebral	1	1
Wound Dehiscence	1	1
Stroke/CVA	1	1
Ischemia	1	1
Pulmonary Emphysema	1	1
Rupture	1	1
Hemorrhage, Cerebral	1	1
Reaction	1	1
Bradycardia	1	1
Fluid Discharge	1	1
Anaphylactic Shock	1	1
Myocardial Infarction	1	1
Embolism	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Jan-05-2024