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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 7617405
Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/20/2017
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
Three anaesthetists; one consultant and two trainees, placed a groshong picc.As they were unfamiliar with the product, one read the ifu while another placed the device, but did not know what the stylet was.The picc was sutured into the patient and left in situ for five days.Drugs were administered until it was noticed that the end of the picc did not look like it usually did.The picc was removed and the stylet was found to be protruding through the valve.There was no reported patient injury.
 
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 of improper procedure is confirmed, use-related.Three photo samples of a groshong nxt clearvue picc were returned for evaluation.An initial visual observation of the photos showed a groshong nxt clearvue picc with the stylet protruding out of the distal end.The first photo sample showed a kink in the middle portion of the catheter.Use residue was observed on the catheter and the stylet.The third photo sample provided appeared to show the stylet exiting out of the valve slit.Based on the description of the reported event and photo samples provided, the complaint of improper procedure is confirmed, use related.The ifu includes step ¿12.Remove the stylet/assembly¿ where it provides insertion instructions.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
Three anaesthetists; one consultant and two trainees, placed a groshong picc.As they were unfamiliar with the product, one read the ifu while another placed the device, but did not know what the stylet was.The picc was sutured into the patient and left in situ for five days.Drugs were administered until it was noticed that the end of the picc did not look like it usually did.The picc was removed and the stylet was found to be protruding through the valve.There was no reported patient injury.
 
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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
shauna nielson
605 n. 5600 w.
salt lake city, UT 84116
8015225536
MDR Report Key7179841
MDR Text Key97007619
Report Number3006260740-2017-02395
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741086991
UDI-Public(01)00801741086991
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K034020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7617405
Device Catalogue Number7617405
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2017
Is the Reporter a Health Professional? No
Event Location Hospital
Date Manufacturer Received01/16/2018
Was Device Evaluated by Manufacturer? Yes
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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