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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

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BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infiltration into Tissue (1931); Thrombus (2101); Discomfort (2330)
Event Date 04/26/2020
Event Type  Injury  
Manufacturer Narrative
The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redn2201 showed two other similar product complaint(s) from this lot number.
 
Event Description
The patient was admitted to hospital because of "middle-thoracic esophageal squamous cell carcinoma", and "picc catheterization" was performed smoothly in accordance with the doctor's instructions on (b)(6) 2020.Planned to remove the picc on (b)(6) 2020.Ultrasound suggested: there are several echo groups attached to the visible wall of the indwelling tube, with the largest reaching 14.5mm × 3.9mm.Consider the thrombosis in walls of the catheter indwelled in the subclavian vein, and give low molecular weight heparin 5000iu q12h anticoagulation therapy.On (b)(6) 2020, vascular b-ultrasound examination showed no abnormity.The picc catheter was removed on the order doctor.The removal process went smoothly and the removed catheter was complete.
 
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Brand Name
GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX  
Manufacturer Contact
kayla olsen
605 n. 5600 w.
salt lake city, UT 84116
8015225010
MDR Report Key10102158
MDR Text Key193028240
Report Number3006260740-2020-01907
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741086991
UDI-Public(01)00801741086991
Combination Product (y/n)N
PMA/PMN Number
K034020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2022
Device Model NumberN/A
Device Catalogue Number7617405
Device Lot NumberREDN2201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 05/09/2020
Initial Date FDA Received05/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
Patient Weight66
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