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TPLC
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show TPLC since
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Device
lavage, jet
Product Code
FQH
Regulation Number
880.5475
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARMIS BIOPHARMA, INC.
SUBSTANTIALLY EQUIVALENT
1
BD
SUBSTANTIALLY EQUIVALENT
1
BECTON, DICKINSON AND COMPANY
SUBSTANTIALLY EQUIVALENT
1
ERBE ELEKTROMEDIZIN GMBH
SUBSTANTIALLY EQUIVALENT
1
INOPRO INC
SUBSTANTIALLY EQUIVALENT
1
IRRIMAX CORPORATION
SUBSTANTIALLY EQUIVALENT
3
NEXT SCIENCE, LLC
SUBSTANTIALLY EQUIVALENT
1
ORTHOPHOR, LLC
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW MEDICAL LIMITED
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
317
317
2019
328
353
2020
393
427
2021
398
450
2022
171
212
2023
290
329
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
175
217
Battery Problem
128
128
No Flow
111
111
Fluid/Blood Leak
97
163
Delivered as Unsterile Product
93
165
Difficult to Insert
79
79
Adverse Event Without Identified Device or Use Problem
67
67
Failure to Prime
62
62
Failure to Power Up
58
58
Mechanical Problem
58
58
Disconnection
57
57
Expulsion
56
56
Break
55
55
Leak/Splash
55
55
Inability to Irrigate
54
54
Improper Flow or Infusion
52
52
Manufacturing, Packaging or Shipping Problem
49
49
Overheating of Device
46
46
Connection Problem
44
44
Defective Device
40
40
Corroded
34
34
Crack
32
32
Appropriate Term/Code Not Available
32
32
Defective Component
30
30
Electrical /Electronic Property Problem
28
28
Noise, Audible
28
28
Pressure Problem
27
27
Biocompatibility
26
26
Infusion or Flow Problem
25
25
Fracture
25
34
Smoking
24
24
Device Contamination with Chemical or Other Material
23
24
Power Problem
21
21
Material Rupture
19
19
Loose or Intermittent Connection
19
19
Packaging Problem
17
17
Melted
13
13
Suction Problem
12
12
Material Integrity Problem
12
12
Component Missing
12
12
Electrical Power Problem
11
11
Inaccurate Flow Rate
11
11
Positioning Problem
10
10
No Pressure
10
10
Protective Measures Problem
10
10
Vibration
10
10
Activation, Positioning or Separation Problem
10
10
Material Deformation
9
9
Device Contaminated During Manufacture or Shipping
9
9
Material Frayed
9
9
Device Emits Odor
9
9
Excessive Heating
9
9
Decrease in Pressure
8
8
Material Separation
8
8
Contamination
8
8
No Apparent Adverse Event
8
8
Inaccurate Delivery
8
8
Obstruction of Flow
7
7
Contamination /Decontamination Problem
7
7
Device Alarm System
7
7
Material Split, Cut or Torn
7
7
Shipping Damage or Problem
6
6
Structural Problem
6
6
Insufficient Information
6
6
Temperature Problem
6
6
Material Twisted/Bent
6
6
Device Dislodged or Dislocated
5
5
Failure to Cut
5
5
Failure to Deliver
5
5
Difficult to Remove
5
5
Insufficient Flow or Under Infusion
4
4
Fitting Problem
4
4
Detachment Of Device Component
4
4
Malposition of Device
4
4
Output Problem
4
4
Mechanical Jam
4
4
Explosion
4
4
Intermittent Loss of Power
4
4
Activation Problem
4
4
Patient Device Interaction Problem
3
3
Activation Failure
3
3
Communication or Transmission Problem
3
3
Device Operates Differently Than Expected
3
3
Tear, Rip or Hole in Device Packaging
3
3
Premature Discharge of Battery
3
3
Thermal Decomposition of Device
3
3
Gas Output Problem
3
3
Material Fragmentation
3
4
No Display/Image
3
3
Loss of Power
3
3
Unsealed Device Packaging
3
3
Increase in Pressure
2
2
Pumping Stopped
2
2
Device Damaged Prior to Use
2
2
Display or Visual Feedback Problem
2
2
Labelling, Instructions for Use or Training Problem
2
2
Burst Container or Vessel
2
2
Loss of or Failure to Bond
2
2
Defective Alarm
2
2
Unintended Power Up
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
891
1031
No Consequences Or Impact To Patient
445
489
No Known Impact Or Consequence To Patient
306
312
No Patient Involvement
196
226
Insufficient Information
44
45
Foreign Body In Patient
31
31
Post Operative Wound Infection
25
25
Impaired Healing
13
13
Injury
12
12
No Code Available
11
11
Hypersensitivity/Allergic reaction
10
10
Burning Sensation
9
9
No Information
8
8
Not Applicable
3
3
Unspecified Infection
3
3
Necrosis
3
3
Device Embedded In Tissue or Plaque
2
2
Embolism/Embolus
1
1
Blister
1
1
Reaction to Medicinal Component of Device
1
1
Sprain
1
1
Tissue Damage
1
1
Wound Dehiscence
1
1
Arrhythmia
1
1
Bruise/Contusion
1
1
Burn(s)
1
1
Stroke/CVA
1
1
Purulent Discharge
1
1
Non specific EKG/ECG Changes
1
1
Erythema
1
1
Hematoma
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
IrriMAX Corporation
II
Oct-24-2019
2
Maquet Cardiovascular, LLC
II
Mar-07-2019
3
Mckesson Medical-Surgical Inc. Corporate Office
III
Sep-26-2022
4
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
II
Nov-20-2018
5
Stryker Instruments Div. of Stryker Corporation
II
Mar-28-2018
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