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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SL BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

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C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SL BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problems Chest Pain (1776); Pain (1994); Foreign Body In Patient (2687)
Event Date 04/25/2021
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redu0827 showed no other similar product complaint(s) from this lot number.
 
Event Description
It reported that six months ago, the patient received picc implantation on the right upper arm.One month later, the patient was discharged without regular admission for maintenance.On april 24, the patient reported that fluid leakage occurred during infusion outside the hospital, the catheter was broken in the body, and the patient felt chest tightness and discomfort.
 
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Brand Name
GROSHONG NXT CLEARVUE 4F SL BASIC TRAY
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX   88780
Manufacturer Contact
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key11890306
MDR Text Key257193334
Report Number3006260740-2021-02049
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741035272
UDI-Public(01)00801741035272
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K034020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/11/2021
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? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number7655405
Device Lot NumberREDU0827
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/06/2021
Initial Date FDA Received05/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2019
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 Age69 YR
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