TPLC - Total Product Life Cycle

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Device	catheter and tip, suction
Regulation Description	Vacuum-powered body fluid suction apparatus.
Product Code	JOL
Regulation Number	880.6740
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Obstruction of Flow	530	530
Leak/Splash	148	148
Suction Problem	87	87
Break	53	53
Material Separation	51	51
Material Integrity Problem	44	44
Adverse Event Without Identified Device or Use Problem	42	42
Unraveled Material	36	36
Device Contaminated During Manufacture or Shipping	31	31
Detachment of Device or Device Component	28	28
Activation Problem	19	19
Use of Device Problem	16	16
Material Deformation	14	14
Difficult to Remove	12	12
No Flow	10	10
Fluid/Blood Leak	8	8
Suction Failure	8	8
Contamination /Decontamination Problem	8	8
Entrapment of Device	7	7
Material Twisted/Bent	7	7
Insufficient Information	7	7
Material Frayed	6	6
Malposition of Device	5	5
Gas/Air Leak	5	5
Material Puncture/Hole	5	5
Delivered as Unsterile Product	4	4
Component Missing	4	4
Patient Device Interaction Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Crack	4	4
Deformation Due to Compressive Stress	4	4
Material Split, Cut or Torn	4	4
Connection Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Device Damaged Prior to Use	3	3
No Apparent Adverse Event	3	3
Physical Resistance/Sticking	3	3
Fitting Problem	3	3
Partial Blockage	3	3
Defective Component	2	2
Difficult to Advance	2	2
Fracture	2	2
Backflow	2	2
Output Problem	2	2
Decrease in Suction	2	2
Sharp Edges	2	2
Device Dislodged or Dislocated	1	1
Overheating of Device	1	1
Migration	1	1
Failure to Disconnect	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	908	908
No Consequences Or Impact To Patient	108	108
Insufficient Information	58	58
Pneumothorax	32	32
Foreign Body In Patient	31	31
No Patient Involvement	16	16
No Code Available	11	11
Unspecified Infection	9	9
Hemorrhage/Bleeding	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Internal Organ Perforation	6	6
Failure to Anastomose	6	6
Pain	6	6
Seroma	6	6
Air Embolism	5	5
Not Applicable	5	5
Inflammation	5	5
Swelling	5	5
Hematoma	4	4
Reaction	4	4
Cardiac Tamponade	4	4
Low Oxygen Saturation	3	3
Necrosis	3	3
Swelling/ Edema	3	3
Pulmonary Emphysema	3	3
No Known Impact Or Consequence To Patient	3	3
Laceration(s)	3	3
Cardiac Perforation	3	3
Pleural Effusion	3	3
Device Embedded In Tissue or Plaque	2	2
Fistula	2	2
Airway Obstruction	2	2
Loss of consciousness	2	2
Unspecified Tissue Injury	2	2
Pneumonia	2	2
Bradycardia	2	2
Needle Stick/Puncture	2	2
Aspiration/Inhalation	2	2
No Information	2	2
Respiratory Distress	2	2
Impaired Healing	2	2
Abdominal Pain	2	2
Exposure to Body Fluids	1	1
Chest Pain	1	1
Cardiac Arrest	1	1
Dyspnea	1	1
Ecchymosis	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Chemical Exposure	1	1
Obstruction/Occlusion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health 200, LLC	I	Feb-16-2024
2	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
3	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
4	Merit Medical Systems, Inc.	II	Aug-12-2024