MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO,4 FR, SINGLE LUMEN FULL TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned 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 innominant vein.Patient brought to interventional radiology for right sided picc placement due to nerve pain at insertion site and malposition of picc.This report address the malposition of the picc.

• Brand Name: POWERPICC SOLO,4 FR, SINGLE LUMEN 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: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 8297635
• MDR Text Key: 134772643
• Report Number: 3006260740-2019-00152
• 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: consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• 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