MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH TIP LOCATION SYSTEM (TLS) STYLET 4F NURSE FULL TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recv2915 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported picc was placed by picc rn at bedside, chest x-ray obtained, x-ray dictated tip of catheter in innominate vein.Patient brought to interventional radiology for right sided picc placement due to nerve pain at insertion site and malposition of picc.Second chest x-ray confirmed foreign object in right ventricle, measuring 6cm.Ct scan performed identifying as wire stylet.X-ray on admission in ed confirmed no metal object at admission.Patient placed on telemetry indicating multiple runs of pvc's.Picc removed, and ir physician removed wire.Wire was sent to pathology for review.Patient on telemetry with no ill effects.This report addresses the wire fragment.

• Brand Name: POWERPICC SOLO CATHETER WITH TIP LOCATION SYSTEM (TLS) STYLET 4F NURSE FULL TRAY
• 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: 8295255
• MDR Text Key: 134692665
• Report Number: 3006260740-2019-00139
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741028595
• UDI-Public: (01)00801741028595
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9194108
• Device Lot Number: RECV2915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• 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