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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device needle, aspiration and injection, disposable
Regulation Description Manual surgical instrument for general use.
Product CodeGAA
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
PNEUMERIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 102 102
2021 107 107
2022 74 74
2023 118 118
2024 183 183
2025 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 197 197
Defective Component 71 71
Break 56 56
Adverse Event Without Identified Device or Use Problem 47 47
Contamination 39 39
Leak/Splash 39 39
Complete Blockage 26 26
Packaging Problem 24 24
Contamination /Decontamination Problem 11 11
Entrapment of Device 11 11
Device Markings/Labelling Problem 10 10
Fracture 7 7
Delivered as Unsterile Product 7 7
Material Twisted/Bent 6 6
Tear, Rip or Hole in Device Packaging 5 5
Component Missing 4 4
Illegible Information 4 4
Detachment of Device or Device Component 4 4
Material Discolored 4 4
Fluid/Blood Leak 3 3
Inaccurate Information 3 3
Defective Device 3 3
Activation, Positioning or Separation Problem 3 3
Material Puncture/Hole 3 3
Improper or Incorrect Procedure or Method 2 2
Disconnection 2 2
Material Separation 2 2
Appropriate Term/Code Not Available 2 2
Device-Device Incompatibility 2 2
Loose or Intermittent Connection 2 2
Unclear Information 2 2
Crack 2 2
Failure to Advance 2 2
Positioning Failure 2 2
Partial Blockage 2 2
Application Network Problem 2 2
Product Quality Problem 2 2
Difficult to Remove 2 2
Migration 2 2
Material Deformation 2 2
Contamination of Device Ingredient or Reagent 2 2
Premature Separation 1 1
Off-Label Use 1 1
Degraded 1 1
High pH 1 1
Difficult to Advance 1 1
Material Protrusion/Extrusion 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Contamination with Body Fluid 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 392 392
No Known Impact Or Consequence To Patient 46 46
No Consequences Or Impact To Patient 33 33
Insufficient Information 32 32
No Patient Involvement 30 30
Foreign Body In Patient 23 23
Endophthalmitis 15 15
Pneumothorax 12 12
Eye Infections 5 5
Hemorrhage/Bleeding 4 4
Intraocular Infection 4 4
Unspecified Tissue Injury 4 4
Needle Stick/Puncture 4 4
Bradycardia 3 3
Inflammation 3 3
No Code Available 3 3
Bronchial Hemorrhage 3 3
Cough 3 3
Low Blood Pressure/ Hypotension 2 2
Unspecified Infection 2 2
Injury 2 2
Abdominal Pain 1 1
Cardiac Arrest 1 1
Unintended Radiation Exposure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Corneal Infiltrates 1 1
Device Embedded In Tissue or Plaque 1 1
Unspecified Eye / Vision Problem 1 1
Nausea 1 1
Pain 1 1
Phlebitis 1 1
Tachycardia 1 1
Urinary Retention 1 1
Visual Impairment 1 1
Vomiting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Hobbs Medical, Inc. II Oct-07-2022
3 INNOVATIVE TOMOGRAPHY PRODUCT GMBH II Jul-29-2021
4 M.D.L. S.r.l. II Sep-20-2021
5 North American Rescue LLC. II Sep-23-2021
6 Tytek Medical Inc II Sep-19-2023
7 Vitreq Bv II Jan-24-2020
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