MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPORT CLEARVUE ISP IMPLANTABLE PORT; PORT, CATHETER, IMPLANTED

Model Number 1608052

Device Problems Break (1069); Device Slipped (1584); Device Fell (4014)

Patient Problem No Information (3190)

Event Date 08/27/2018

Event Type  malfunction  

Event Description

The physician went to attach the powerport to the tubing and the part that slides into the tubing just fell off into three pieces.

• Brand Name: POWERPORT CLEARVUE ISP IMPLANTABLE PORT
• Type of Device: PORT, CATHETER, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 7863692
• MDR Text Key: 119821739
• Report Number: 7863692
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026423
• UDI-Public: (01)00801741026423
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1608052
• Device Catalogue Number: 1608052
• Device Lot Number: RECR2215
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2018
• Type of Device Usage: N
• Patient Sequence Number: 1