MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PICC 4 FR POWER TRAY; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 119194108D

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/26/2018

Event Type  Injury  

Event Description

The right sided picc line was attempted to be removed from the brachial vein.Resistance was met.Five cm remained in patient.Picc was originally cut at 48 cm but only 43 were removed.Patient had to go to interventional radiology and have remainder of picc removed.

• Brand Name: PICC 4 FR POWER TRAY
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 7710036
• MDR Text Key: 114689892
• Report Number: 7710036
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 119194108D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 26645 DA
• Patient Weight: 82