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
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8295255
• Report Number: 3006260740-2019-00139
• Device Sequence Number: 19368440
• Product Code: LJS
• UDI-Device Identifier: 00801741028595
• UDI-Public: (01)00801741028595
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9194108
• Device Lot Number: RECV2915
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention