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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT WITH STRIPED CATH 4F SINGLE LUMEN BASIG JAPAN HANG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS GROSHONG NXT WITH STRIPED CATH 4F SINGLE LUMEN BASIG JAPAN HANG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Catalog Number 7617405J
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2018
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, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rebw1364 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the connector and lock sleeve were connected by applying stronger force than usual because they were too tight; as a result, blood backflow was not confirmed and flushing failed, so the device was exchanged for another.The catheter connector, the lock sleeve and a part of the catheter to be returned.There was no reported patient injury.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 an occluded catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 4fr s/l groshong catheter.Usage residues were observed on the sample.The sample was received assembled with a two-piece connector.The catheter terminated approximately 10cm distal of the two-piece connector.The catheter appeared bunched where it exited from the connector.A gap was evident between the two segments of the connector.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be fully occluded.Following longitudinal bisection of the distal connector segment, inspection of the catheter confirmed that it was bunched and folded within the bore.The compression sleeve was advanced nearly halfway into the narrow region of the bore.Microscopic inspection of the sample confirmed that the catheter was bunched and folded within the bore and that the compression sleeve was over-advanced.The crumpled and folded state of the catheter and the position of the compression sleeve were consistent with attempting connector assembly over a bunched and compressed catheter.Such catheter bunching occurs if the catheter is advanced too far onto the connector cannula prior to assembly.The product ifu states ¿gently advance the catheter onto the connector blunt until it butts up against the colored plastic body.The catheter should lie flat on the blunt without any kinks.¿ a lot history review (lhr) of rebw1364 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the connector and lock sleeve were connected by applying stronger force than usual because they were too tight; as a result, blood backflow was not confirmed and flushing failed, so the device was exchanged for another.The catheter connector, the lock sleeve and a part of the catheter to be returned.There was no reported patient injury.
 
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Brand Name
GROSHONG NXT WITH STRIPED CATH 4F SINGLE LUMEN BASIG JAPAN HANG
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
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key7584436
MDR Text Key110849988
Report Number3006260740-2018-01308
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
Date FDA Received06/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7617405J
Device Lot NumberREBW1364
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
Date Manufacturer Received06/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2017
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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