MAUDE Adverse Event Report: UNKNOWN UNKNOWN INTRAVENOUS (IV); SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Unspecified Infection (1930)

Event Date 04/23/2014

Event Type  Injury  

Event Description

It was reported that the iv line delivering the antibiotics to the patient became infected and the patient was readmitted to treat this infection and resulting cellulitis from (b)(6) 2014 through (b)(6) 2014.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN INTRAVENOUS (IV)
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17528835
• MDR Text Key: 321081531
• Report Number: MW5135764
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1