MAUDE Adverse Event Report: UNKNOWN; POWER PORT

UNKNOWN; POWER PORT

Device Problem Difficult to Flush (1251)

Patient Problem No Information (3190)

Event Date 01/21/2019

Event Type Injury

Event Description

Pt had a non-functioning central venous access port and it was surgically explanted.Another port was surgically implanted in the right subclavian.

1 Device was Involved in the Event
Brand Name	UNKNOWN
Type of Device	POWER PORT
MDR Report Key	8288824
MDR Text Key	134703889
Report Number	8288824
Device Sequence Number	1
Product Code	LJT
Combination Product (y/n)	N
Reporter Country Code	US
Number of Events Reported	1
Summary Report (Y/N)	N
Report Source	User Facility
Reporter Occupation	Risk Manager
Type of Report	Initial
Report Date	01/22/2019
1 Patient was Involved in the Event
Date FDA Received	01/23/2019
Is this an Adverse Event Report?	No
Is this a Product Problem Report?	Yes
Device Operator	Health Professional
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	01/22/2019
Distributor Facility Aware Date	01/21/2019
Event Location	Hospital
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 Outcome(s)	Hospitalization;
Patient Age	70 YR
Patient Weight	88