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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
2018 122 122
2019 153 153
2020 102 102
2021 107 107
2022 74 74
2023 82 82

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 240 240
Break 97 97
Leak/Splash 40 40
Contamination 29 29
Adverse Event Without Identified Device or Use Problem 27 27
Complete Blockage 23 23
Packaging Problem 22 22
Contamination /Decontamination Problem 21 21
Fracture 19 19
Delivered as Unsterile Product 14 14
Detachment of Device or Device Component 13 13
Device Markings/Labelling Problem 13 13
Dull, Blunt 11 11
Material Twisted/Bent 9 9
Insufficient Information 8 8
Component Missing 7 7
Entrapment of Device 7 7
Use of Device Problem 5 5
Material Fragmentation 5 5
Crack 5 5
Defective Device 5 5
Appropriate Term/Code Not Available 5 5
Contamination of Device Ingredient or Reagent 4 4
Material Discolored 4 4
Defective Component 4 4
Material Puncture/Hole 4 4
Illegible Information 4 4
Material Separation 3 3
Signal Artifact/Noise 3 3
Detachment Of Device Component 3 3
Loose or Intermittent Connection 3 3
Activation, Positioning or Separation Problem 3 3
Device Dislodged or Dislocated 3 3
Material Deformation 3 3
Material Split, Cut or Torn 3 3
Device Operates Differently Than Expected 3 3
Obstruction of Flow 2 2
Failure to Deliver 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure to Advance 2 2
Failure to Obtain Sample 2 2
Suction Failure 2 2
Mechanical Problem 2 2
Short Fill 2 2
Device Damaged Prior to Use 2 2
Improper or Incorrect Procedure or Method 2 2
Product Quality Problem 2 2
Difficult to Remove 2 2
Unsealed Device Packaging 2 2
Fluid/Blood Leak 2 2
Inaccurate Information 2 2
Migration 2 2
Unclear Information 1 1
Occlusion Within Device 1 1
Unintended Collision 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
Fitting Problem 1 1
Material Perforation 1 1
Inadequacy of Device Shape and/or Size 1 1
Migration or Expulsion of Device 1 1
Hole In Material 1 1
Difficult to Insert 1 1
Corroded 1 1
Degraded 1 1
Premature Separation 1 1
Device Handling Problem 1 1
Positioning Problem 1 1
Torn Material 1 1
Unintended Movement 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
Separation Failure 1 1
Physical Resistance 1 1
Device Contamination with Body Fluid 1 1
High pH 1 1
Patient-Device Incompatibility 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Difficult to Advance 1 1
Difficult to Open or Remove Packaging Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 223 223
No Clinical Signs, Symptoms or Conditions 207 207
No Consequences Or Impact To Patient 63 63
No Patient Involvement 39 39
Foreign Body In Patient 31 31
Pneumothorax 14 14
No Information 12 12
No Code Available 10 10
Insufficient Information 9 9
Injury 6 6
Hemorrhage/Bleeding 6 6
Inflammation 6 6
Needle Stick/Puncture 6 6
Unspecified Tissue Injury 4 4
Bronchial Hemorrhage 3 3
Device Embedded In Tissue or Plaque 3 3
Pain 3 3
Local Reaction 2 2
Scarring 2 2
Cough 2 2
Unintended Radiation Exposure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Not Applicable 1 1
Patient Problem/Medical Problem 1 1
Deformity/ Disfigurement 1 1
Reaction 1 1
Corneal Infiltrates 1 1
Discomfort 1 1
Tachycardia 1 1
Tissue Damage 1 1
Pneumonia 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Myocardial Infarction 1 1
Necrosis 1 1
Abdominal Pain 1 1
Abscess 1 1
Exposure to Body Fluids 1 1
Bruise/Contusion 1 1
Cardiac Arrest 1 1
Endophthalmitis 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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