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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
Product CodeGAA
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
PNEUMERIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 153 153
2020 102 102
2021 107 107
2022 74 74
2023 118 118
2024 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 220 220
Break 76 76
Leak/Splash 45 45
Adverse Event Without Identified Device or Use Problem 36 36
Contamination 30 30
Complete Blockage 24 24
Packaging Problem 22 22
Contamination /Decontamination Problem 13 13
Device Markings/Labelling Problem 12 12
Delivered as Unsterile Product 11 11
Defective Component 10 10
Detachment of Device or Device Component 9 9
Dull, Blunt 9 9
Material Twisted/Bent 9 9
Entrapment of Device 8 8
Fracture 8 8
Component Missing 7 7
Insufficient Information 6 6
Use of Device Problem 5 5
Crack 5 5
Illegible Information 4 4
Device Dislodged or Dislocated 3 3
Defective Device 3 3
Tear, Rip or Hole in Device Packaging 3 3
Contamination of Device Ingredient or Reagent 3 3
Activation, Positioning or Separation Problem 3 3
Signal Artifact/Noise 3 3
Material Separation 3 3
Material Puncture/Hole 3 3
Material Discolored 3 3
Difficult to Remove 2 2
Short Fill 2 2
Device Damaged Prior to Use 2 2
Failure to Deliver 2 2
Partial Blockage 2 2
Material Fragmentation 2 2
Loose or Intermittent Connection 2 2
Device-Device Incompatibility 2 2
Failure to Advance 2 2
Material Deformation 2 2
Inaccurate Information 2 2
Appropriate Term/Code Not Available 2 2
Migration 2 2
Material Split, Cut or Torn 2 2
Suction Failure 2 2
Separation Problem 1 1
Premature Separation 1 1
Ejection Problem 1 1
Device Handling Problem 1 1
Unclear Information 1 1
Device Contaminated at the User Facility 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Unintended Movement 1 1
Failure to Obtain Sample 1 1
Separation Failure 1 1
Patient-Device Incompatibility 1 1
Obstruction of Flow 1 1
High pH 1 1
Failure to Align 1 1
Difficult to Advance 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Damaged by Another Device 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Difficult to Insert 1 1
Loss of or Failure to Bond 1 1
Degraded 1 1
Corroded 1 1
Device Contamination with Body Fluid 1 1
Inadequacy of Device Shape and/or Size 1 1
Improper or Incorrect Procedure or Method 1 1
Material Perforation 1 1
Product Quality Problem 1 1
Unintended Collision 1 1
Unsealed Device Packaging 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 261 261
No Known Impact Or Consequence To Patient 147 147
No Consequences Or Impact To Patient 40 40
No Patient Involvement 34 34
Foreign Body In Patient 27 27
Insufficient Information 16 16
Pneumothorax 13 13
No Information 11 11
No Code Available 8 8
Hemorrhage/Bleeding 6 6
Needle Stick/Puncture 6 6
Intraocular Infection 4 4
Unspecified Tissue Injury 4 4
Injury 4 4
Bronchial Hemorrhage 3 3
Cough 3 3
Endophthalmitis 3 3
Inflammation 3 3
Bradycardia 3 3
Low Blood Pressure/ Hypotension 2 2
Scarring 2 2
Device Embedded In Tissue or Plaque 2 2
Pain 2 2
Pneumonia 1 1
Corneal Infiltrates 1 1
Deformity/ Disfigurement 1 1
Unintended Radiation Exposure 1 1
Unspecified Eye / Vision Problem 1 1
Tachycardia 1 1
Urinary Retention 1 1
Vomiting 1 1
Laceration(s) 1 1
Myocardial Infarction 1 1
Nausea 1 1
Unspecified Infection 1 1
Bruise/Contusion 1 1
Cardiac Arrest 1 1
Abdominal Pain 1 1
Exposure to Body Fluids 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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