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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 FR. SL GROSHONG NXT CONNECTOR REPAIR KIT; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
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BARD ACCESS SYSTEMS 4 FR. SL GROSHONG NXT CONNECTOR REPAIR KIT; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER Back to Search Results
Model Number 7812400
Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2017
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rezc1715 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported by the nurse that liquid leakage was found to occur on the extension tube when the head nurse was making the dressing change for the patient, which was thus replaced with a new one.However, the tail end of the catheter failed to pass through the pressure reduction sleeve after relevant preparations have been made.The head nurse alleged that there were burrs on the pressure reduction sleeve and replaced the catheter with a brand new one (model: 7812400).The replacement of extension tube was completed smoothly.
 
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 a leaking catheter was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 4fr s/l groshong nxt clearvue catheter.The sample was received assembled with a two-piece connector.Usage residues were observed throughout the sample.The extension tubing markings were partially worn.The catheter terminated approximately 3cm distal of the connector strain-relief sleeve.Microscopic inspection of the distal end of the sample revealed striations typical of a sharp instrument cut.An attempt to infuse water through the sample using a12ml syringe revealed the sample to be patent to infusion with no observed leaks.No leaks were observed during sustained hydraulic pressurization of the sample.Microscopic inspection of the sample did not reveal any evidence of leakage.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.
 
Event Description
It was reported by the nurse that liquid leakage was found to occur on the extension tube when the head nurse was making the dressing change for the patient, which was thus replaced with a new one.However, the tail end of the catheter failed to pass through the pressure reduction sleeve after relevant preparations have been made.The head nurse alleged that there were burrs on the pressure reduction sleeve and replaced the catheter with a brand new one (model: 7812400).The replacement of extension tube was completed smoothly.
 
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Brand Name
4 FR. SL GROSHONG NXT CONNECTOR REPAIR KIT
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
teresa johnson
605 n. 5600 w.
salt lake city, UT 84116
8015225435
MDR Report Key6576004
MDR Text Key75667016
Report Number3006260740-2017-00640
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741075261
UDI-Public(01)00801741075261(17)200330(10)REZC1715
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
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 07/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/30/2020
Device Model Number7812400
Device Catalogue Number7812400
Device Lot NumberREZC1715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2017
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received06/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2015
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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