MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD POWER PICC SV CATHETER NON-CUFFED SINGLE LUMEN PICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Lot Number REBX2406

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 02/04/2018

Event Type  malfunction  

Event Description

Picc line fragment was retained after removal of picc line.

• Brand Name: BARD POWER PICC SV CATHETER NON-CUFFED SINGLE LUMEN PICC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; salt lake city UT 84116
• MDR Report Key: 7273092
• MDR Text Key: 100246481
• Report Number: MW5075249
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Lot Number: REBX2406
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 MO