MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWER PORT SLIM LINE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1716000

Device Problem Expiration Date Error (2528)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

Expired power port implanted into patient on (b)(6) 2020.Noted later that port expired on 04/30/2020.Fda safety report id# (b)(4).

• Brand Name: POWER PORT SLIM LINE
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 10657280
• MDR Text Key: 211101169
• Report Number: MW5097162
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026744
• UDI-Public: 00801741026744
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 1716000
• Device Catalogue Number: 1716000
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 64