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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 Problems Break (1069); Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2018
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that the groshong catheter was damaged.Reportedly, the picc system was implanted for chemotherapy in (b)(6) 2018.On (b)(6) 2018, blood collection via the catheter couldn¿t be performed and fluoroscopy revealed that the distal of the catheter advanced too far toward the heart.Upon removing the catheter outside the patient, the alleged catheter damage, which had been slightly inserted into the patient, was found.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 catheter damage was confirmed and the cause was determined to be use related.The product returned for evaluation was a 4fr s/l groshong nxt clearvue picc.The sample contained usage residue throughout and an injection cap was attached to the luer hub.Gross visual evaluation of the device found a ~1.5mm region of catheter damage between the 36cm and 37cm depth markings.The sample was patent to infusion using water and a 12ml syringe and a spraying leak was seen from the aforementioned damage site.Microscopic examination of that site showed that the damage was rough, granular, and topographically complex.The damage site was then cut from the sample and bisected longitudinally in order to inspect the condition of the inner catheter surface.The interior surface contained damage which was not visible from the exterior.Several parallel, diagonally oriented, abrasive lines were seen on the interior surface which led into the damage site observed from the exterior of the catheter.The damage features were characteristic of damage caused during retraction of the stiffening stylet.The product ifu states, ¿preflush catheter with sterile normal saline or heparinized saline to wet stylet.¿ the ifu also states, ¿never use force to remove the stylet.Resistance can damage the catheter.If resistance or bunching of the catheter is observed, stop stylet withdrawal and allow the catheter to return to normal shape.Withdraw both the catheter and stylet together approximately 2 cm and reattempt stylet removal.Repeat this procedure until the stylet is easily removed.¿ the precautions in the ifu state, ¿avoid device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps.Do not use the catheter if there is any evidence of mechanical damage or leaking.¿ a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that the groshong catheter was damaged.Reportedly, the picc system was implanted for chemotherapy in (b)(6) 2018.On (b)(6) 2018, blood collection via the catheter couldn¿t be performed and fluoroscopy revealed that the distal of the catheter advanced too far toward the heart.Upon removing the catheter outside the patient, the alleged catheter damage, which had been slightly inserted into the patient, was found.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 Key7675920
MDR Text Key113743114
Report Number3006260740-2018-01664
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,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/03/2018
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 Number7617405J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2018
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/10/2018
Supplement Dates Manufacturer Received07/13/2018
Supplement Dates FDA Received08/03/2018
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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