MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD POWER PICC LINE CATHTER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Lot Number CK000452

Device Problem Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 07/25/2019

Event Type  Injury  

Event Description

Retained picc line fragment in right ventricle of heart. Patient taken to interventional radiology for image guided retrieval of foreign body. Fda safety report id # (b)(4).

• Brand Name: BARD POWER PICC LINE
• Type of Device: CATHTER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; salt lake city UT 84116
• MDR Report Key: 9086991
• MDR Text Key: 159373604
• Report Number: MW5089898
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/30/2019
• Device Lot Number: CK000452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 09/18/2019 Patient Sequence Number: 1