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TPLC
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Device
catheter, irrigation
Regulation Description
Introduction/drainage catheter and accessories.
Product Code
GBX
Regulation Number
878.4200
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
198
198
2021
383
383
2022
477
477
2023
629
629
2024
945
945
2025
81
81
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
896
896
Break
422
422
Fluid/Blood Leak
266
266
Material Separation
262
262
Defective Component
245
245
Adverse Event Without Identified Device or Use Problem
134
134
Leak/Splash
112
112
Device Contaminated During Manufacture or Shipping
81
81
Infusion or Flow Problem
76
76
Material Fragmentation
75
75
Dull, Blunt
59
59
Device Contamination with Chemical or Other Material
45
45
Material Integrity Problem
40
40
Disconnection
38
38
Unraveled Material
29
29
Detachment of Device or Device Component
26
26
No Apparent Adverse Event
25
25
Deformation Due to Compressive Stress
24
24
Obstruction of Flow
22
22
Suction Failure
21
21
Suction Problem
21
21
Difficult to Remove
20
20
Material Split, Cut or Torn
17
17
Contamination /Decontamination Problem
16
16
Material Twisted/Bent
15
15
Component Misassembled
15
15
Restricted Flow rate
14
14
Entrapment of Device
13
13
Crack
12
12
Fitting Problem
10
10
Difficult to Insert
10
10
Use of Device Problem
10
10
Material Puncture/Hole
10
10
Improper or Incorrect Procedure or Method
8
8
Device Damaged Prior to Use
8
8
Appropriate Term/Code Not Available
8
8
Physical Resistance/Sticking
7
7
Material Deformation
7
7
Wrong Label
7
7
Material Too Soft/Flexible
6
6
Failure to Advance
6
6
Malposition of Device
5
5
Migration or Expulsion of Device
5
5
Particulates
5
5
Partial Blockage
5
5
Decrease in Suction
5
5
Tear, Rip or Hole in Device Packaging
5
5
Component Missing
5
5
Difficult to Flush
5
5
Incorrect Measurement
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2103
2103
Foreign Body In Patient
181
181
No Consequences Or Impact To Patient
120
120
Insufficient Information
77
77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
65
65
Unspecified Infection
40
40
No Known Impact Or Consequence To Patient
27
27
No Patient Involvement
23
23
Pain
23
23
Hemorrhage/Bleeding
22
22
Hematoma
21
21
Endophthalmitis
21
21
Pneumothorax
19
19
Seroma
19
19
Failure to Anastomose
18
18
Fistula
14
14
No Code Available
13
13
Not Applicable
12
12
Post Operative Wound Infection
11
11
Wound Dehiscence
10
10
Extravasation
9
9
Inflammation
8
8
Pleural Effusion
8
8
Bacterial Infection
8
8
Failure of Implant
8
8
Necrosis
8
8
Toxic Anterior Segment Syndrome (TASS)
8
8
Device Embedded In Tissue or Plaque
7
7
Obstruction/Occlusion
6
6
Abscess
6
6
Pneumonia
6
6
Cardiac Tamponade
6
6
Erythema
5
5
Thrombosis/Thrombus
4
4
Impaired Healing
4
4
Hypoxia
4
4
Fever
4
4
Low Blood Pressure/ Hypotension
4
4
Atrial Fibrillation
4
4
Unspecified Tissue Injury
4
4
Sepsis
4
4
Uveitis
4
4
Capsular Bag Tear
4
4
Infiltration into Tissue
3
3
Conjunctivitis
3
3
Numbness
3
3
Cellulitis
3
3
Low Oxygen Saturation
3
3
No Information
3
3
Abdominal Pain
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
II
May-01-2024
2
Cardinal Health 200, LLC
II
Jan-18-2023
3
Centese Inc.
II
Oct-13-2021
4
Cook Inc.
II
Mar-24-2020
5
Maquet Cardiovascular, LLC
II
Jan-19-2023
6
TELEFLEX MEDICAL INC
II
Mar-24-2021
7
TELEFLEX MEDICAL INC
II
Aug-28-2020
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