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TPLC
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show TPLC since
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Device
lavage, jet
Regulation Description
Jet lavage.
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
2020
393
427
2021
398
450
2022
171
208
2023
333
372
2024
425
480
2025
50
54
Device Problems
MDRs with this Device Problem
Events in those MDRs
Delivered as Unsterile Product
244
320
Battery Problem
187
187
Detachment of Device or Device Component
176
253
Inability to Irrigate
107
107
Failure to Power Up
81
81
Fluid/Blood Leak
77
122
Overheating of Device
71
71
Adverse Event Without Identified Device or Use Problem
70
70
Failure to Prime
58
58
Manufacturing, Packaging or Shipping Problem
52
52
Crack
51
51
Difficult to Insert
48
48
Improper Flow or Infusion
47
47
Device Contaminated During Manufacture or Shipping
43
45
Connection Problem
43
43
Explosion
40
40
Pressure Problem
39
39
Break
38
38
No Flow
35
35
Noise, Audible
30
30
Expulsion
29
29
Fracture
26
45
Appropriate Term/Code Not Available
23
23
Power Problem
22
22
Electrical /Electronic Property Problem
22
22
Material Rupture
22
22
Disconnection
22
22
Infusion or Flow Problem
21
21
Defective Device
20
20
Packaging Problem
20
20
Leak/Splash
19
19
Loose or Intermittent Connection
19
19
Corroded
19
19
Activation Problem
18
18
Smoking
17
17
Device Contamination with Chemical or Other Material
15
16
Suction Problem
12
12
Defective Component
11
11
Activation, Positioning or Separation Problem
11
11
Mechanical Problem
11
11
Protective Measures Problem
10
10
Melted
10
10
Vibration
10
10
Material Frayed
9
9
Material Twisted/Bent
9
9
Contamination
9
9
Material Separation
9
9
Material Split, Cut or Torn
8
8
Decrease in Pressure
8
8
Contamination /Decontamination Problem
8
8
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1391
1585
No Consequences Or Impact To Patient
193
218
No Patient Involvement
78
104
No Known Impact Or Consequence To Patient
72
72
Insufficient Information
55
60
Post Operative Wound Infection
26
26
Impaired Healing
13
13
Hypersensitivity/Allergic reaction
11
11
Foreign Body In Patient
10
11
Burning Sensation
9
9
Rash
6
6
No Information
6
6
Injury
6
6
Laceration(s)
3
3
Necrosis
3
3
Unspecified Infection
3
3
No Code Available
2
2
Burn(s)
2
2
Dyspnea
2
2
Swelling/ Edema
2
2
Sepsis
1
1
Tissue Damage
1
1
Embolism/Embolus
1
1
Wound Dehiscence
1
1
Aspiration/Inhalation
1
1
Stroke/CVA
1
1
Purulent Discharge
1
1
Erythema
1
1
Blister
1
1
Reaction to Medicinal Component of Device
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Mckesson Medical-Surgical Inc. Corporate Office
III
Sep-26-2022
2
Medtronic Perfusion Systems
II
May-10-2024
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