TPLC - Total Product Life Cycle

• Device: circuit, breathing (w connector, adaptor, y piece)
• Product Code: CAI
• Regulation Number: 868.5240
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2018	39	39
2019	62	62
2020	71	71
2021	138	138
2022	244	244

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	130	130
Gas/Air Leak	114	114
Material Puncture/Hole	22	22
Loose or Intermittent Connection	21	21
Crack	21	21
Defective Component	20	20
Material Deformation	18	18
Disconnection	18	18
Detachment of Device or Device Component	16	16
Fitting Problem	16	16
Connection Problem	14	14
Break	13	13
Material Integrity Problem	11	11
Component Missing	10	10
Material Split, Cut or Torn	9	9
Contamination /Decontamination Problem	8	8
Inflation Problem	8	8
Tear, Rip or Hole in Device Packaging	7	7
Fluid/Blood Leak	6	6
Gas Output Problem	5	5
Obstruction of Flow	5	5
Material Twisted/Bent	4	4
Device Damaged Prior to Use	4	4
Device Slipped	4	4
Fracture	4	4
Product Quality Problem	4	4
Pressure Problem	4	4
Insufficient Information	4	4
Appropriate Term/Code Not Available	3	3
Separation Problem	3	3
Air/Gas in Device	3	3
Delivered as Unsterile Product	3	3
Shipping Damage or Problem	3	3
Inadequacy of Device Shape and/or Size	3	3
Misconnection	3	3
Material Fragmentation	3	3
Incomplete or Missing Packaging	3	3
Defective Device	3	3
Device Displays Incorrect Message	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Device Operates Differently Than Expected	3	3
Infusion or Flow Problem	2	2
Blocked Connection	2	2
Failure to Deliver	2	2
Microbial Contamination of Device	2	2
Improper or Incorrect Procedure or Method	2	2
Loss of or Failure to Bond	2	2
Material Perforation	2	2
Complete Blockage	2	2
Device Alarm System	2	2
Deflation Problem	2	2
Material Discolored	2	2
Mechanical Problem	2	2
Occlusion Within Device	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Material Too Rigid or Stiff	2	2
Unintended Deflation	2	2
Physical Resistance/Sticking	2	2
No Flow	2	2
No Pressure	2	2
Packaging Problem	1	1
Power Problem	1	1
Noise, Audible	1	1
Therapeutic or Diagnostic Output Failure	1	1
Misassembly by Users	1	1
Premature Separation	1	1
Unexpected Color	1	1
Material Separation	1	1
Decrease in Pressure	1	1
Melted	1	1
Moisture Damage	1	1
Difficult to Insert	1	1
Decoupling	1	1
Defective Alarm	1	1
Partial Blockage	1	1
Hole In Material	1	1
Material Disintegration	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
Fire	1	1
Insufficient Flow or Under Infusion	1	1
Tidal Volume Fluctuations	1	1
Use of Device Problem	1	1
Deformation Due to Compressive Stress	1	1
Improper Flow or Infusion	1	1
Compatibility Problem	1	1
Moisture or Humidity Problem	1	1
Difficult to Open or Close	1	1
Failure of Device to Self-Test	1	1
Device Markings/Labelling Problem	1	1
Failure to Disconnect	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	337	337
No Patient Involvement	73	73
No Consequences Or Impact To Patient	50	50
No Known Impact Or Consequence To Patient	33	33
Insufficient Information	22	22
Hypoxia	7	7
Low Oxygen Saturation	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Respiratory Distress	6	6
No Information	4	4
Foreign Body In Patient	2	2
Hypoventilation	2	2
Viral Infection	2	2
Bacterial Infection	2	2
Burn(s)	1	1
Cardiopulmonary Arrest	1	1
Death	1	1
Dyspnea	1	1
Pain	1	1
Apnea	1	1
Aspiration/Inhalation	1	1
Extubate	1	1
Irritability	1	1
Respiratory Failure	1	1
Decreased Respiratory Rate	1	1
Electric Shock	1	1
Chemical Exposure	1	1
Patient Problem/Medical Problem	1	1
Respiratory Distress Syndrome of Newborns	1	1
Swelling	1	1
No Code Available	1	1
Balance Problems	1	1
Test Result	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Intersurgical Inc	II	Jun-27-2018
2	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
3	Medline Industries Inc	II	Dec-18-2019