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	620	620
Leak/Splash	177	177
Suction Problem	87	87
Break	70	70
Material Separation	66	66
Material Integrity Problem	51	51
Adverse Event Without Identified Device or Use Problem	46	49
Unraveled Material	37	37
Device Contaminated During Manufacture or Shipping	31	31
Detachment of Device or Device Component	31	31
Device Dislodged or Dislocated	20	20
Activation Problem	19	19
Use of Device Problem	17	17
Material Deformation	14	14
Difficult to Remove	12	12
No Flow	10	10
Expulsion	9	9
Deformation Due to Compressive Stress	9	9
Entrapment of Device	9	9
Fluid/Blood Leak	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
Gas/Air Leak	7	7
Material Frayed	6	6
Connection Problem	6	6
Improper or Incorrect Procedure or Method	5	5
Crack	5	5
Material Puncture/Hole	5	5
Material Split, Cut or Torn	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 Markings/Labelling Problem	3	3
Device Damaged Prior to Use	3	3
Physical Resistance/Sticking	3	3
Fitting Problem	3	3
Backflow	2	2
Therapeutic or Diagnostic Output Failure	2	2
Decrease in Suction	2	2
Defective Device	2	2
Sharp Edges	2	2
Defective Component	2	2
Difficult to Advance	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1055	1055
No Consequences Or Impact To Patient	108	108
Insufficient Information	86	86
Foreign Body In Patient	42	42
Pneumothorax	39	39
No Patient Involvement	16	16
Unspecified Infection	11	11
No Code Available	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Hemorrhage/Bleeding	9	9
Failure to Anastomose	7	7
Low Oxygen Saturation	6	6
Internal Organ Perforation	6	6
Pain	6	6
Seroma	6	6
Air Embolism	5	5
Not Applicable	5	5
Hematoma	5	5
Inflammation	5	5
Swelling	5	8
Swelling/ Edema	4	4
Reaction	4	4
Pneumonia	4	4
Laceration(s)	4	4
Cardiac Tamponade	4	4
Pleural Effusion	3	3
Cardiac Perforation	3	3
No Known Impact Or Consequence To Patient	3	3
Pulmonary Emphysema	3	3
Necrosis	3	3
Needle Stick/Puncture	2	2
Device Embedded In Tissue or Plaque	2	2
Fistula	2	2
Aspiration/Inhalation	2	2
Abdominal Pain	2	2
Dyspnea	2	2
Impaired Healing	2	2
No Information	2	2
Airway Obstruction	2	2
Bradycardia	2	2
Unspecified Tissue Injury	2	2
Respiratory Distress	2	2
Loss of consciousness	2	2
Distress	1	1
Bruise/Contusion	1	1
Respiratory Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Hemothorax	1	1
Cancer	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