MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD POWERPICC PROVENA DOUBLE LUMEN 4F; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number S1294108D1

Device Problems Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/29/2021

Event Type  Injury  

Event Description

A powerpicc provena, polyurethane picc catheter with solo valve technology was inserted on (b)(6) 2021 using lot number refw0154.Three (3) linear radiopaque foreign bodies are seen, one in the svc/atrium, one in the posterior right liver and one in the right lower lobe.These appear to represent wire fragments.Fda safety report id# (b)(4).

• Brand Name: BARD POWERPICC PROVENA DOUBLE LUMEN 4F
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 13152031
• MDR Text Key: 283301550
• Report Number: MW5106431
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741154799
• UDI-Public: (01)00801741154799
• 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: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: S1294108D1
• Device Catalogue Number: S1294108D1
• Device Lot Number: REFW0154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic