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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device guide, needle, surgical
Product CodeGDF
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2017 6 6
2018 7 7
2019 13 13
2020 14 14
2021 9 9
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 14 14
Signal Artifact/Noise 9 9
Device Markings/Labelling Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Difficult to Remove 4 4
Image Display Error/Artifact 4 4
Nonstandard Device 3 3
Detachment of Device or Device Component 3 3
Migration or Expulsion of Device 2 2
Crack 2 2
Device Operates Differently Than Expected 2 2
Difficult to Advance 2 2
Biocompatibility 2 2
Activation, Positioning or Separation Problem 1 1
Material Separation 1 1
Improper or Incorrect Procedure or Method 1 1
Cut In Material 1 1
Failure to Advance 1 1
Positioning Failure 1 1
Material Fragmentation 1 1
Insufficient Information 1 1
Device Fell 1 1
Gas/Air Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 17 17
No Clinical Signs, Symptoms or Conditions 11 11
No Known Impact Or Consequence To Patient 7 7
No Patient Involvement 6 6
Foreign Body In Patient 4 4
Pneumothorax 3 3
Injury 3 3
Excessive Tear Production 1 1
Incontinence 1 1
Unspecified Infection 1 1
Pain 1 1
Not Applicable 1 1
No Information 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II May-02-2017
2 M.D.L. S.r.l. II Sep-20-2021
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