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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 PICC BASIC TRAY (WITH MICROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Failure to Infuse (2340); Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/05/2019
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recz1886 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that when the operator checked flush and the blood return to confirm the catheter patency just after insertion of the groshong catheter via the left upper arm, infusion and aspiration could not be performed.When the catheter was removed and another catheter was replaced, infusion and aspiration could be performed without problem.There was no reported patient injury.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of the catheter being unable to infuse or aspirate was confirmed and appears to be related to the use of the device.One 4 fr sl groshong nxt catheter was returned for investigation.The two-piece connector and extension leg were returned unassembled.Residual material was present within the catheter tubing.The extension leg was flushed with water using a 12 ml syringe and was found to be patent to infusion and aspiration.An attempt to flush the groshong catheter revealed it to be occluded with the residual material.The distal end of the catheter was cut proximal to the valve location to test valve functionality.The distal segment was flushed with water and was found to be patent to infusion and aspiration.Microscopic observation of the valve revealed no apparent issues.The valve slit length was measured and found to be within specification.The dried residue within the catheter obstructed fluid flow.Since the source of the occlusion was found to be residual use material, the complaint is confirmed.The product instructions for use suggests, "flushing for intermittent use, flush the catheter with saline once each week or after each use.Note: when infusion volume is a concern in small or pediatric patients, flush with 3ml per lumen.Caution: to reduce potential for blood backflow into the catheter tip, always remove needles or needleless caps slowly while injecting the last 0.5 ml of saline." a lot history review (lhr) of recz1886 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that when the operator checked flush and the blood return to confirm the catheter patency just after insertion of the groshong catheter via the left upper arm, infusion and aspiration could not be performed.When the catheter was removed and another catheter was replaced, infusion and aspiration could be performed without problem.There was no reported patient injury.
 
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Brand Name
GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER)
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
MDR Report Key8920474
MDR Text Key155488716
Report Number3006260740-2019-02446
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
Type of Report Initial,Followup
Report Date 09/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number7655405J
Device Lot NumberRECZ1886
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2019
Event Location Hospital
Date Manufacturer Received09/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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