TPLC - Total Product Life Cycle

• Device: needle, fistula
• Product Code: FIE
• Regulation Number: 876.5540
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BAIN MEDICAL EQUIPMENT (GUANGZHOU)CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	21	21
2020	3	3
2021	1	1
2022	1	1
2023	58	68
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	39	39
Fluid/Blood Leak	11	11
Device Dislodged or Dislocated	9	9
Output Problem	6	6
Detachment of Device or Device Component	5	5
Device Slipped	4	14
Leak/Splash	3	3
Device Difficult to Setup or Prepare	3	3
Difficult to Remove	2	2
Unstable	2	12
Break	2	2
Expulsion	2	2
Material Integrity Problem	2	2
Fail-Safe Did Not Operate	2	2
Positioning Problem	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Physical Resistance/Sticking	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Component Missing	1	1
Dull, Blunt	1	1
Patient-Device Incompatibility	1	1
Material Separation	1	1
Device Appears to Trigger Rejection	1	1
Mechanical Problem	1	1
No Audible Alarm	1	1
Backflow	1	1
Partial Blockage	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hemorrhage/Bleeding	38	38
Hemolysis	14	14
Insufficient Information	13	13
Pain	13	13
Blood Loss	6	6
Needle Stick/Puncture	4	14
Hypovolemia	4	4
Discomfort	3	13
Loss of consciousness	3	3
Low Blood Pressure/ Hypotension	2	2
Failure of Implant	2	2
Infiltration into Tissue	1	1
Nausea	1	1
Anaphylactic Shock	1	1
Bruise/Contusion	1	1
Cardiac Arrest	1	1
Cardiopulmonary Arrest	1	1
Death	1	1
Dyspnea	1	1
Exsanguination	1	1
Impaired Healing	1	1
Stenosis	1	1
Shock	1	1
Skin Discoloration	1	1
Hypersensitivity/Allergic reaction	1	1
Neck Pain	1	1
Post Operative Wound Infection	1	1
Diaphoresis	1	1
Skin Tears	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1