TPLC - Total Product Life Cycle

• Device: tube, tracheal/bronchial, differential ventilation (w/wo connector)
• Product Code: CBI
• Regulation Number: 868.5740
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AMBU A/S
	SUBSTANTIALLY EQUIVALENT	1
HYTEK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSUNG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PULMONX CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	94	94
2020	87	87
2021	159	159
2022	127	127
2023	94	94
2024	13	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	200	200
Gas/Air Leak	68	68
Inflation Problem	62	62
Leak/Splash	51	51
Deflation Problem	17	17
Fracture	13	13
Mechanical Problem	13	13
Crack	11	11
Material Deformation	11	11
Component Missing	10	10
Material Separation	8	8
Material Rupture	7	7
Use of Device Problem	7	7
Infusion or Flow Problem	7	7
Ejection Problem	7	7
Material Split, Cut or Torn	6	6
Material Twisted/Bent	6	6
Separation Failure	6	6
Output Problem	5	5
Material Puncture/Hole	5	5
Incomplete or Missing Packaging	5	5
Obstruction of Flow	5	5
Unsealed Device Packaging	5	5
Disconnection	4	4
Device Damaged Prior to Use	4	4
Defective Component	4	4
Contamination /Decontamination Problem	4	4
Detachment of Device or Device Component	3	3
Device Markings/Labelling Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Packaging Problem	3	3
Material Too Soft/Flexible	3	3
Failure to Deflate	3	3
Unintended Deflation	3	3
Failure to Unfold or Unwrap	3	3
Inadequacy of Device Shape and/or Size	2	2
Fitting Problem	2	2
Fluid/Blood Leak	2	2
Complete Blockage	2	2
Labelling, Instructions for Use or Training Problem	2	2
Incomplete or Inadequate Connection	2	2
Deformation Due to Compressive Stress	2	2
Defective Device	2	2
Material Integrity Problem	2	2
Device Contaminated During Manufacture or Shipping	2	2
Manufacturing, Packaging or Shipping Problem	2	2
No Flow	1	1
Blocked Connection	1	1
Connection Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Activation Problem	1	1
Separation Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
No Apparent Adverse Event	1	1
Appropriate Term/Code Not Available	1	1
Device Handling Problem	1	1
Physical Resistance/Sticking	1	1
Sharp Edges	1	1
Device Fell	1	1
Loose or Intermittent Connection	1	1
Decrease in Pressure	1	1
Misconnection	1	1
Delivered as Unsterile Product	1	1
Contamination	1	1
Burst Container or Vessel	1	1
Material Perforation	1	1
Failure to Disconnect	1	1
Solder Joint Fracture	1	1
Product Quality Problem	1	1
Material Too Rigid or Stiff	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	344	344
No Consequences Or Impact To Patient	74	74
Insufficient Information	45	45
No Patient Involvement	45	45
No Known Impact Or Consequence To Patient	29	29
Low Oxygen Saturation	11	11
Extubate	11	11
No Information	9	9
Respiratory Failure	8	8
Hypoxia	7	7
Ventilator Dependent	4	4
Decreased Respiratory Rate	4	4
Pain	3	3
Obstruction/Occlusion	2	2
Exsanguination	2	2
Pulmonary Embolism	2	2
Airway Obstruction	2	2
No Code Available	2	2
Patient Problem/Medical Problem	2	2
Unintended Extubation	2	2
Device Embedded In Tissue or Plaque	1	1
Respiratory Insufficiency	1	1
Unspecified Kidney or Urinary Problem	1	1
Foreign Body In Patient	1	1
Bradycardia	1	1
Chest Pain	1	1
Death	1	1
Hemorrhage/Bleeding	1	1
Low Blood Pressure/ Hypotension	1	1
Laceration(s)	1	1
Decreased Peak Expiratory Flow rate	1	1
Pneumothorax	1	1
Sepsis	1	1
Septic Shock	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ambu Inc.	II	Jul-20-2022
2	Teleflex Medical	II	Dec-18-2019