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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
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BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN Back to Search Results
Catalog Number 7655405
Device Problems Loose or Intermittent Connection (1371); Retraction Problem (1536)
Patient Problem Embolus (1830)
Event Type  Injury  
Event Description
It was reported that "picc line was in patient's arm.While it's in situ one of the connections became lose and retracted into the patient's arm.The picc line has to be removed from the patient via angiogram.".
 
Manufacturer Narrative
The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reye0599 showed no other similar product complaint(s) from these lot numbers.
 
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Brand Name
GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN
Manufacturer (Section D)
BARD ACCESS SYSTEMS
salt lake city UT
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V.
blvd montebello #1
parque industrial colonial
reynose, tamaulipas
MX  
Manufacturer Contact
christy chandonia
605 north 5600 west
salt lake city, UT 84116
8015224969
MDR Report Key4593796
MDR Text Key5632719
Report Number3006260740-2015-00117
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
PMA/PMN Number
K034020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/18/2015
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 Other
Device Catalogue Number7655405
Device Lot NumberREYE0599
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 02/18/2015
Initial Date FDA Received03/09/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2014
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;
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