TPLC - Total Product Life Cycle

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Device	spinal epidural anesthesia kit
Regulation Description	Anesthesia conduction catheter.
Definition	This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product Code	OFT
Regulation Number	868.5120
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	37	37
Leak/Splash	27	27
Appropriate Device Problem Term/Code Not Available	25	25
Material Integrity Problem	13	13
Fluid/Blood Leak	8	8
Insufficient Device Problem Information	6	6
Material Fragmentation	5	5
Connection Problem	5	5
Contamination	5	5
Mechanical Problem	4	4
Loose or Intermittent Connection	4	4
Difficult to Advance	3	3
Obstruction of Flow	3	3
Crack	2	2
Defective Device	2	2
Failure to Infuse	2	2
Failure to Deliver	2	2
Device Slipped	2	2
Material Puncture/Hole	2	2
Material Too Soft/Flexible	2	2
Output Problem	2	2
Material Twisted/Bent	2	2
Contamination /Decontamination Problem	2	2
Physical Resistance/Sticking	1	1
Particulates	1	1
Premature Activation	1	1
Difficult to Remove	1	1
Device Handling Problem	1	1
Stretched	1	1
Defective Component	1	1
Component Missing	1	1
Dull, Blunt	1	1
Material Deformation	1	1
Infusion or Flow Problem	1	1
Improper Flow or Infusion	1	1
Complete Blockage	1	1
Device Contamination with Chemical or Other Material	1	1
Fail-Safe Problem	1	1
Difficult or Delayed Positioning	1	1
Disconnection	1	1
Detachment of Device or Device Component	1	1
Difficult to Flush	1	1
Incomplete or Inadequate Connection	1	1
Failure to Seal	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	110	110
Foreign Body In Patient	34	34
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	18	18
Insufficient Information	13	13
Needle Stick/Puncture	9	9
Headache	8	8
Pain	7	7
Inadequate Pain Relief	2	2
Device Embedded In Tissue or Plaque	2	2
Low Blood Pressure/ Hypotension	2	2
Laceration(s)	1	1
Spinal Arachnoiditis	1	1
Abrasion	1	1
No Information	1	1
Failure of Implant	1	1
Discomfort	1	1
Osteomyelitis	1	1
Dyspnea	1	1
Muscle Weakness/Atrophy	1	1
Nerve Damage	1	1
No Consequences Or Impact To Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	B Braun Medical Inc	II	May-29-2026
2	B. Braun Medical, Inc.	II	Jan-24-2025
3	MEDLINE INDUSTRIES, LP - Northfield	II	Apr-17-2025
4	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-25-2025
5	MEDLINE INDUSTRIES, LP - Northfield	II	Dec-05-2024
6	MEDLINE INDUSTRIES, LP - Northfield	II	Nov-22-2024
7	MEDLINE INDUSTRIES, LP - Northfield	II	Oct-23-2024
8	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-28-2024
9	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-27-2024
10	MEDLINE INDUSTRIES, LP - Northfield	I	Aug-08-2024
11	MEDLINE INDUSTRIES, LP - Northfield	II	Aug-03-2023
12	MEDLINE INDUSTRIES, LP - Northfield	II	Jul-20-2023
13	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-10-2023
14	MEDLINE INDUSTRIES, LP - Northfield	II	Feb-06-2023
15	Medline Industries, LP	II	Jun-29-2026
16	Medline Industries, LP	II	Jun-12-2026
17	Medline Industries, LP	I	May-28-2026
18	Medline Industries, LP	II	May-07-2026
19	Medline Industries, LP	II	Apr-30-2026
20	Medline Industries, LP	II	Feb-17-2026
21	Medline Industries, LP	II	Jan-28-2026
22	Medline Industries, LP	II	Nov-14-2025