TPLC - Total Product Life Cycle

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Device	catheter, hemodialysis, non-implanted
Regulation Description	Blood access device and accessories.
Product Code	MPB
Regulation Number	876.5540
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Puncture/Hole	142	142
Material Deformation	89	89
Material Twisted/Bent	78	78
Difficult to Remove	77	77
Unraveled Material	74	74
Break	73	73
Material Frayed	66	66
Fluid/Blood Leak	65	66
Deformation Due to Compressive Stress	60	60
Product Quality Problem	48	48
Crack	42	42
Leak/Splash	33	33
Obstruction of Flow	33	33
Physical Resistance/Sticking	28	28
Component Incompatible	26	26
Material Separation	26	26
Detachment of Device or Device Component	23	23
Adverse Event Without Identified Device or Use Problem	23	23
Migration	21	21
Defective Component	20	20
Insufficient Flow or Under Infusion	13	13
Disconnection	11	11
Contamination /Decontamination Problem	10	10
Migration or Expulsion of Device	9	9
Material Split, Cut or Torn	9	9
Failure to Infuse	9	9
Material Fragmentation	8	8
Insufficient Information	7	7
Device Markings/Labelling Problem	7	7
Device Slipped	7	7
Infusion or Flow Problem	7	7
Material Integrity Problem	6	6
Difficult to Insert	6	6
Difficult to Advance	5	5
Air/Gas in Device	4	4
Gas/Air Leak	4	4
Suction Failure	3	3
Output Problem	3	3
Loose or Intermittent Connection	3	3
Mechanical Problem	3	3
Fitting Problem	3	3
Separation Problem	3	3
Suction Problem	3	3
Device Dislodged or Dislocated	3	3
Unsealed Device Packaging	2	2
Contamination	2	2
Device Damaged Prior to Use	2	2
Unintended Ejection	2	2
Component Missing	2	2
Improper or Incorrect Procedure or Method	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	807	807
Insufficient Information	119	120
Hemorrhage/Bleeding	24	24
Foreign Body In Patient	16	16
Hematoma	11	11
Air Embolism	7	7
Unintended Radiation Exposure	7	7
Unspecified Infection	6	6
No Consequences Or Impact To Patient	6	6
Cardiac Arrest	5	5
Fever	4	4
Needle Stick/Puncture	4	4
Pain	4	4
Swelling/ Edema	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Failure of Implant	3	3
Exsanguination	3	3
Low Oxygen Saturation	3	3
Thrombosis/Thrombus	3	3
Arrhythmia	2	2
Distress	2	2
Embolism/Embolus	2	2
Decreased Respiratory Rate	2	2
Low Blood Pressure/ Hypotension	2	2
Chills	2	2
Erythema	2	2
Loss of consciousness	2	2
Bacterial Infection	2	2
Bradycardia	2	2
Hypovolemia	1	1
Hemothorax	1	1
Unspecified Vascular Problem	1	1
Headache	1	1
Blurred Vision	1	1
Hypoxia	1	1
Stenosis	1	1
Perforation of Vessels	1	1
Asystole	1	1
Pneumonia	1	1
Laceration(s)	1	1
Dyspnea	1	1
Alteration in Body Temperature	1	1
Discomfort	1	1
Burning Sensation	1	1
Peritonitis	1	1
Cardiac Tamponade	1	1
Perforation	1	1
Muscle Weakness	1	1
Ischemia	1	1
Pneumothorax	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mozarc Medical US LLC	II	Jun-05-2026