TPLC - Total Product Life Cycle

• Device: stylet, tracheal tube
• Regulation Description: Tracheal tube stylet.
• Product Code: BSR
• Regulation Number: 868.5790
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2020	5	5
2021	11	11
2022	5	5
2023	19	19
2024	31	31
2025	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Defective Device	11	11
Break	9	9
Crack	9	9
Material Separation	6	6
Detachment of Device or Device Component	5	5
Use of Device Problem	4	4
Defective Component	3	3
Failure to Disconnect	3	3
Physical Resistance/Sticking	2	2
Device Markings/Labelling Problem	2	2
Material Integrity Problem	2	2
Difficult to Remove	2	2
Material Too Rigid or Stiff	2	2
Gas/Air Leak	2	2
Device Handling Problem	2	2
Appropriate Term/Code Not Available	2	2
Material Too Soft/Flexible	2	2
Unstable	1	1
Entrapment of Device	1	1
Device Damaged Prior to Use	1	1
Insufficient Information	1	1
Device Fell	1	1
Contamination /Decontamination Problem	1	1
Material Fragmentation	1	1
Obstruction of Flow	1	1
Fracture	1	1
Human-Device Interface Problem	1	1
Flaked	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	35	35
Insufficient Information	14	14
Foreign Body In Patient	8	8
Unintended Extubation	4	4
Laceration(s)	3	3
Apnea	2	2
Bronchial Hemorrhage	2	2
Aspiration/Inhalation	2	2
Bronchospasm	2	2
Swelling/ Edema	2	2
Respiratory Distress Syndrome of Newborns	2	2
Airway Obstruction	2	2
No Code Available	1	1
Perforation	1	1
Obstruction/Occlusion	1	1
Pain	1	1
Hypoxia	1	1
No Consequences Or Impact To Patient	1	1
Low Oxygen Saturation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Smiths Medical ASD, Inc.	II	Nov-25-2024