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TPLC
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Device
needle, aspiration and injection, disposable
Regulation Description
Manual surgical instrument for general use.
Product Code
GAA
Regulation Number
878.4800
Device Class
1
Premarket Reviews
Manufacturer
Decision
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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