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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
Catalog Number 7655405J
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2018
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebx0907 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that during the placement procedure, when inserting the catheter, confirming the position of the distal end part of the catheter by x-ray, the distal end part of the catheter seemed forked into y-shape, therefore the catheter was removed from the patient.As there was no visual defect on the removed catheter, the catheter was re-inserted.However, under x-ray, the distal end part of the catheter seemed y-shaped.Therefore, the catheter was removed and the procedure was completed by the use of another kit.The physician thought that the catheter seemed forked because the stylet might have pierced the catheter.
 
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 a abnormal catheter tip x-ray imaging is inconclusive due to unknown clinical conditions.One 4 fr groshong catheter was returned for investigation.The stylet was returned within the catheter with the flushing hub.A bend was observed at the 39 cm depth marker.Use residue was observed within the catheter.The sample was flushed with water using a 10 ml syringe and was found to be patent to infusion.It was then pressurized and no leaks were observed.The stylet was removed from the catheter.Microscopic observation of the stylet revealed no apparent damage.The distal end was intact.No apparent defects were observed and the equipment in which the aligned complaint occurred was not available.Due to the inability to replicate the clinical conditions in which the alleged complaint occurred, the complaint is inconclusive.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rebx0907 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that during the placement procedure, when inserting the catheter, confirming the position of the distal end part of the catheter by x-ray, the distal end part of the catheter seemed forked into y-shape, therefore the catheter was removed from the patient.As there was no visual defect on the removed catheter, the catheter was re-inserted.However, under x-ray, the distal end part of the catheter seemed y-shaped.Therefore, the catheter was removed and the procedure was completed by the use of another kit.The physician thought that the catheter seemed forked because the stylet might have pierced the catheter.
 
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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
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX  
Manufacturer Contact
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key7574090
MDR Text Key110360399
Report Number3006260740-2018-01237
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K034020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7655405J
Device Lot NumberREBX0907
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2018
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/06/2018
Supplement Dates Manufacturer Received06/14/2018
Supplement Dates FDA Received06/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2017
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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