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

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/03/2022

Event Type  malfunction  

Event Description

Power picc line placed and upon cxr for placement noted 1.3 cm metal fragment was noted in chest.Fragment not causing issues and risk to remove greater than leaving in place.Fda safety report id # (b)(4).

• Brand Name: BARD POWER PICC
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 13534421
• MDR Text Key: 285642544
• Report Number: MW5107418
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 MO
• Patient Sex: Male
• Patient Weight: 13 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American