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	637	638
Leak/Splash	189	189
Break	69	69
Material Separation	62	62
Material Integrity Problem	55	55
Adverse Event Without Identified Device or Use Problem	36	36
Unraveled Material	36	36
Device Contaminated During Manufacture or Shipping	29	29
Detachment of Device or Device Component	29	30
Device Dislodged or Dislocated	20	20
Activation Problem	19	19
Use of Device Problem	17	17
Suction Failure	13	13
Material Deformation	11	11
Material Twisted/Bent	11	11
No Flow	10	10
Deformation Due to Compressive Stress	10	10
Difficult to Remove	10	10
Expulsion	9	9
Entrapment of Device	8	8
Gas/Air Leak	8	8
Fluid/Blood Leak	7	7
Malposition of Device	7	7
Insufficient Information	7	7
Improper or Incorrect Procedure or Method	6	6
Connection Problem	6	6
Suction Problem	6	6
Material Puncture/Hole	6	6
Crack	5	5
Patient Device Interaction Problem	5	5
Lack of Effect	4	4
No Apparent Adverse Event	3	3
Component Missing	3	3
Physical Resistance/Sticking	3	4
Therapeutic or Diagnostic Output Failure	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Device Markings/Labelling Problem	3	3
Defective Device	3	3
Material Frayed	2	2
Material Split, Cut or Torn	2	2
Fracture	2	3
Migration	2	2
Output Problem	2	2
Packaging Problem	2	2
Delivered as Unsterile Product	2	2
Patient-Device Incompatibility	2	2
Difficult to Advance	2	2
Defective Component	2	2
Material Discolored	2	2
Material Fragmentation	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1114	1116
Insufficient Information	95	95
Pneumothorax	40	40
Foreign Body In Patient	40	40
Unspecified Infection	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Hemorrhage/Bleeding	10	11
Failure to Anastomose	7	7
Seroma	7	7
Swelling/ Edema	6	6
Low Oxygen Saturation	6	6
Pain	5	5
Hematoma	5	5
Inflammation	5	5
Internal Organ Perforation	5	5
Air Embolism	4	4
Pneumonia	4	4
Laceration(s)	4	4
Cardiac Tamponade	4	4
Dyspnea	3	3
Necrosis	3	3
Pulmonary Emphysema	3	3
Airway Obstruction	3	3
Pleural Effusion	3	3
Cardiac Perforation	3	4
Unspecified Tissue Injury	2	2
Bradycardia	2	2
Needle Stick/Puncture	2	2
Aspiration/Inhalation	2	2
Fistula	2	2
Wound Dehiscence	2	2
Impaired Healing	2	2
Abdominal Pain	2	2
Bacterial Infection	1	1
Loss of consciousness	1	1
Cancer	1	1
Hemothorax	1	1
Unspecified Respiratory Problem	1	1
Low Blood Pressure/ Hypotension	1	1
Respiratory Failure	1	1
Partial thickness (Second Degree) Burn	1	1
Bruise/Contusion	1	1
Device Embedded In Tissue or Plaque	1	1
Pseudoaneurysm	1	1
Skin Tears	1	1
Increased Respiratory Rate	1	1
Perforation of Vessels	1	1
Tachycardia	1	1
Shock	1	1
Extravasation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health 200, LLC	I	Feb-16-2024
2	Cook Incorporated	II	Apr-06-2026
3	MEDLINE INDUSTRIES, LP - Northfield	I	Feb-25-2024
4	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
5	Medline Industries, LP	II	May-07-2026
6	Medline Industries, LP	II	Feb-17-2026
7	Merit Medical Systems, Inc.	II	Aug-12-2024