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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device operating room accessories table tray
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 CodeFWZ
Regulation Number 878.4950
Device Class 1

MDR Year MDR Reports MDR Events
2019 99 99
2020 464 464
2021 337 337
2022 56 56
2023 28 28
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 328 328
Unintended Movement 107 107
Unstable 81 81
Device Slipped 79 79
Loose or Intermittent Connection 58 58
Positioning Problem 43 43
Deformation Due to Compressive Stress 39 39
Break 36 36
Physical Resistance/Sticking 31 31
Mechanics Altered 30 30
Positioning Failure 29 29
Device Handling Problem 28 28
Fitting Problem 18 18
Leak/Splash 17 17
Adverse Event Without Identified Device or Use Problem 17 17
Naturally Worn 16 16
Mechanical Jam 16 16
Decrease in Pressure 13 13
Material Integrity Problem 12 12
Insufficient Information 9 9
Fluid/Blood Leak 9 9
Connection Problem 9 9
Component Missing 7 7
Detachment of Device or Device Component 6 6
Material Deformation 5 5
Material Twisted/Bent 4 4
Difficult to Open or Close 4 4
Device Dislodged or Dislocated 4 4
Failure to Cut 4 4
Defective Device 4 4
Use of Device Problem 3 3
Low Readings 3 3
Noise, Audible 3 3
Material Split, Cut or Torn 3 3
Failure to Eject 2 2
Failure to Clean Adequately 2 2
Material Separation 2 2
Device-Device Incompatibility 2 2
Fracture 2 2
Material Fragmentation 2 2
Problem with Removal of Enzymatic Cleaner 2 2
Collapse 1 1
Crack 1 1
Material Frayed 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Material Rupture 1 1
Nonstandard Device 1 1
Unintended System Motion 1 1
Contamination /Decontamination Problem 1 1
Patient-Device Incompatibility 1 1
Battery Problem 1 1
Incomplete or Missing Packaging 1 1
Device Damaged Prior to Use 1 1
Sharp Edges 1 1
Device Fell 1 1
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Appropriate Term/Code Not Available 1 1
Pressure Problem 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 386 386
No Known Impact Or Consequence To Patient 275 275
No Consequences Or Impact To Patient 151 151
No Patient Involvement 114 114
Laceration(s) 22 22
Insufficient Information 13 13
No Information 13 13
Injury 10 10
Fall 4 4
Pain 3 3
Needle Stick/Puncture 2 2
Skin Tears 1 1
Ambulation Difficulties 1 1
Limb Fracture 1 1
Blister 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Paresis 1 1
Swelling 1 1
Tissue Damage 1 1
Fasciitis 1 1
Necrosis 1 1
Nerve Damage 1 1
Bone Fracture(s) 1 1
Hemorrhage/Bleeding 1 1
Unspecified Infection 1 1
Inflammation 1 1
Abrasion 1 1
Airway Obstruction 1 1
Bacterial Infection 1 1
Bruise/Contusion 1 1
Cellulitis 1 1
Erythema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Mar-12-2024
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