TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
11	3	5	3	11	0

MDR Year	MDR Reports	MDR Events
2021	9	9
2022	12	12
2023	14	14
2024	24	24
2025	15	15

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	28	28
Break	27	27
Patient-Device Incompatibility	5	5
Crack	4	4
Device Handling Problem	2	2
Fluid/Blood Leak	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Shipping Damage or Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Tear, Rip or Hole in Device Packaging	1	1
Obstruction of Flow	1	1
Material Twisted/Bent	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	38	38
Pericardial Effusion	7	7
Cardiac Tamponade	4	4
Hemorrhage/Bleeding	4	4
Unspecified Infection	3	3
Insufficient Information	3	3
Abscess	3	3
Aspiration Pneumonitis	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Pneumothorax	2	2
Inflammation	2	2
Pleural Effusion	2	2
Bacterial Infection	2	2
Stroke/CVA	1	1
Pulmonary Emphysema	1	1
Atrial Fibrillation	1	1
Post Operative Wound Infection	1	1
Injury	1	1
Bradycardia	1	1
Fluid Discharge	1	1
Pneumonia	1	1
Anaphylactic Shock	1	1
No Consequences Or Impact To Patient	1	1
Pulmonary Embolism	1	1

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