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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; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER
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BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER Back to Search Results
Model Number N/A
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2017
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reax1618 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reax1618) have been reported from the same (b)(4) facility.
 
Event Description
It was reported by the nurse that the catheter was in normal integrity by examination before catheter placement.It was found that drawing could not be conducted during catheter placement.It was stated that after multiple adjustments, the nurse was still unable to draw.The catheter was thus changed.Drawing still could not be conducted in vitro after taking out the catheter, along with difficult injection.No patient harm was reported.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint that the catheter failed to aspirate was confirmed, but the cause is unknown.A 4 fr s/l groshong picc was returned for investigation.One groshong s/l 4 fr picc was received with the stylet in the lumen.The hang tag was still attached to the catheter.The two-piece connector was received in two pieces separate from the catheter.No blood residue was observed in the catheter.Repeated functional tests of the catheter confirmed that the valve failed to open inward for aspiration both with and without the stylet.The valve opened outward during infusion and no leaks were detected in the catheter.A microscopic examination of the valve cut showed nothing remarkable.The valve length was within specification.This could be associated with insufficient lubricant on the valve.It is unknown if the lubricant was affected by the clinical procedure.At this time, based on the condition of the returned sample, it is unknown what prevented the valve from opening for aspiration.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.
 
Event Description
It was reported by the nurse that the catheter was in normal integrity by examination before catheter placement.It was found that drawing could not be conducted during catheter placement.It was stated that after multiple adjustments, the nurse was still unable to draw.The catheter was thus changed.Drawing still could not be conducted in vitro after taking out the catheter, along with difficult injection.No patient harm was reported.
 
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Brand Name
GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER
Type of Device
PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER
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
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key6647805
MDR Text Key77941765
Report Number3006260740-2017-00807
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741086991
UDI-Public(01)00801741086991(17)210430(10)REAX1618
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 company representative,other
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 07/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2021
Device Model NumberN/A
Device Catalogue Number7617405
Device Lot NumberREAX1618
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2017
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received07/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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