MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY

Catalog Number 7617405

Device Problem Human-Device Interface Problem (2949)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2013

Event Type  malfunction  

Event Description

The user cut the catheter tube without removing the stylet; the stylet remained inside the patient body.The stylet was removed 15 days after placement.The user admitted that this event was a user-related issue.

Manufacturer Narrative

The complaint of a damaged stylet wire is confirmed and will be reported as user-related.No manufacturing defect were observed during gross and microscopic examinations.Returned for evaluation is a section of a flush through stiffener styler wire that is contained in a groshong 4 fr picc clearvue catheter.The damaged stylet wire was returned loose.Gross and microscopic examinations reveal multiple bends proximal to the distal end of the wire.The proximal end of the stylet wire contains evidence it was cut with a sharp instrument.The distal tip of the styler terminates with its manufactured blunt and round end.Presumably the wire and catheter were cut simultaneously prior to the assembly of the two piece connector.Note: this has been reported in the complaint incident report by the complainant.It can be presumed the small gauged stylet wire had been grasped by some type of snare device and pulled through the narrow confines of a patient's vasculature.Placement of a picc catheter with the wire remaining in place is not recommended by the manufacturer.The product ifu directs the user to remove the stiffener stylet prior to trimming the catheter to length and attaching it to the 4 fr two piece connector.A lot history review (lhr) is not possible, as no manufacturing lot number info has been provided by the complainant.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY
• Manufacturer (Section D): C.R. BARD, INC. (BASD); salt lake city UT
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shelly gilbert ; 605 north 5600 west; salt lake city, UT 84116 ; 8015950700
• MDR Report Key: 3711303
• MDR Text Key: 4336024
• Report Number: 3006260740-2014-00007
• 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: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7617405
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/31/2013
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/20/2013
• 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
• Patient Outcome(s): Required Intervention