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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device manometer, spinal-fluid
Product CodeFMJ
Regulation Number 880.2500
Device Class 2


Premarket Reviews
ManufacturerDecision
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 176 176
2015 84 84
2019 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment Of Device Component 247 247
Needle, separation 36 36
Fail-Safe Design Failure 6 6
Difficult or Delayed Activation 3 3
Bent 2 2
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 237 237
Therapy/non-surgical treatment, additional 12 12
No Known Impact Or Consequence To Patient 8 8
No Information 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Death 1 1
Chemical Exposure 1 1
Needle Stick/Puncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Busse Hospital Disposables, Inc. II May-28-2022
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