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

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.

• 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 Key: 7675920
• MDR Text Key: 113743114
• Report Number: 3006260740-2018-01664
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• 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 Number: 7617405J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2018
• Supplement Dates Manufacturer Received: 07/13/2018
• Supplement Dates FDA Received: 08/03/2018
• 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 Number: 1