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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, suction, patient care
Regulation Description Patient care suction apparatus.
Product CodeDWM
Regulation Number 870.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
BEARPAC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCKET MEDICAL PLC
  SUBSTANTIALLY EQUIVALENT - KIT 1

MDR Year MDR Reports MDR Events
2020 68 68
2021 143 143
2022 62 62
2023 108 108
2024 71 71
2025 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Break 66 66
Adverse Event Without Identified Device or Use Problem 54 54
Material Separation 49 49
Fluid/Blood Leak 40 40
Fracture 33 33
Detachment of Device or Device Component 29 29
Leak/Splash 28 28
Sharp Edges 27 27
Material Puncture/Hole 21 21
Complete Blockage 13 13
Unsealed Device Packaging 13 13
Tear, Rip or Hole in Device Packaging 9 9
Device Handling Problem 9 9
Material Twisted/Bent 9 9
Product Quality Problem 8 8
Migration 7 7
Contamination 7 7
Defective Component 6 6
Obstruction of Flow 6 6
Material Split, Cut or Torn 5 5
Crack 4 4
Device Dislodged or Dislocated 4 4
Packaging Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Device Markings/Labelling Problem 3 3
Separation Failure 3 3
Device Contamination with Chemical or Other Material 3 3
Loose or Intermittent Connection 2 2
Component Misassembled 2 2
Use of Device Problem 2 2
Difficult to Insert 2 2
Suction Failure 2 2
Restricted Flow rate 2 2
Disconnection 2 2
Decrease in Suction 1 1
Improper Flow or Infusion 1 1
Component Missing 1 1
Stretched 1 1
Air/Gas in Device 1 1
Patient Device Interaction Problem 1 1
Difficult to Remove 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Expiration Date Error 1 1
Missing Information 1 1
Insufficient Information 1 1
Device Appears to Trigger Rejection 1 1
Suction Problem 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 317 317
No Consequences Or Impact To Patient 76 76
Insufficient Information 35 35
Pneumothorax 16 16
Unspecified Infection 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Pain 12 12
Foreign Body In Patient 9 9
Cellulitis 7 7
Peritonitis 7 7
Bacterial Infection 7 7
Discomfort 5 5
Pleural Empyema 4 4
Radiation Exposure, Unintended 3 3
No Code Available 3 3
Skin Inflammation/ Irritation 3 3
Ascites 3 3
Death 2 2
Inflammation 2 2
Obstruction/Occlusion 2 2
Pleural Effusion 2 2
Skin Infection 1 1
Failure of Implant 1 1
Sepsis 1 1
Vascular Dissection 1 1
Hematoma 1 1
Electrolyte Imbalance 1 1
No Known Impact Or Consequence To Patient 1 1
Erythema 1 1
Skin Inflammation 1 1
Dyspnea 1 1
Pneumonia 1 1
Unspecified Respiratory Problem 1 1
Loss of consciousness 1 1
Low Blood Pressure/ Hypotension 1 1
Decreased Respiratory Rate 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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