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	583	583
Leak/Splash	159	159
Suction Problem	87	87
Break	61	61
Material Separation	61	61
Material Integrity Problem	48	48
Adverse Event Without Identified Device or Use Problem	43	43
Unraveled Material	36	36
Device Contaminated During Manufacture or Shipping	31	31
Detachment of Device or Device Component	30	30
Activation Problem	19	19
Use of Device Problem	16	16
Material Deformation	14	14
Difficult to Remove	12	12
No Flow	10	10
Expulsion	9	9
Fluid/Blood Leak	8	8
Deformation Due to Compressive Stress	8	8
Entrapment of Device	8	8
Malposition of Device	8	8
Suction Failure	8	8
Contamination /Decontamination Problem	8	8
Insufficient Information	7	7
Material Twisted/Bent	7	7
Material Frayed	6	6
Connection Problem	6	6
Crack	5	5
Material Puncture/Hole	5	5
Gas/Air Leak	5	5
Material Split, Cut or Torn	4	4
Improper or Incorrect Procedure or Method	4	4
Delivered as Unsterile Product	4	4
Lack of Effect	4	4
Component Missing	4	4
Patient Device Interaction Problem	4	4
No Apparent Adverse Event	3	3
Partial Blockage	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Device Damaged Prior to Use	3	3
Physical Resistance/Sticking	3	3
Fitting Problem	3	3
Backflow	2	2
Decrease in Suction	2	2
Defective Component	2	2
Sharp Edges	2	2
Difficult to Advance	2	2
Output Problem	2	2
Migration	2	2
Fracture	2	2
Air/Gas in Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	989	989
No Consequences Or Impact To Patient	108	108
Insufficient Information	76	76
Pneumothorax	39	39
Foreign Body In Patient	33	33
No Patient Involvement	16	16
No Code Available	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Unspecified Infection	9	9
Hemorrhage/Bleeding	9	9
Low Oxygen Saturation	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
Reaction	4	4
Laceration(s)	4	4
Cardiac Tamponade	4	4
Hematoma	4	4
No Known Impact Or Consequence To Patient	3	3
Cardiac Perforation	3	3
Pulmonary Emphysema	3	3
Pleural Effusion	3	3
Necrosis	3	3
Swelling/ Edema	3	3
Fistula	2	2
Device Embedded In Tissue or Plaque	2	2
Airway Obstruction	2	2
Aspiration/Inhalation	2	2
Needle Stick/Puncture	2	2
Impaired Healing	2	2
No Information	2	2
Abdominal Pain	2	2
Dyspnea	2	2
Pneumonia	2	2
Bradycardia	2	2
Loss of consciousness	2	2
Unspecified Tissue Injury	2	2
Respiratory Distress	2	2
Bruise/Contusion	1	1
Distress	1	1
Hemothorax	1	1
Respiratory Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Wound Dehiscence	1	1
Bacterial Infection	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