MAUDE Adverse Event Report: BD HEPARIN PRE-FILLED FLUSHES

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/26/2018

Event Type  Injury  

Event Description

Pt had been admitted to our pediatric icu from (b)(6) 2017 - (b)(6) 2018, then transferred to our medical/surgical unit.Developed positive blood cultures with serratia marcescens on (b)(6) 2018.Event abated after use stopped or dose reduced: no.Event reappeared after reintroduction: yes.Therapy started date: (b)(6) 2017; therapy end date: (b)(6) 2018.

• Brand Name: HEPARIN PRE-FILLED FLUSHES
• Type of Device: HEPARIN PRE-FILLED FLUSHES
• Manufacturer (Section D): BD
• MDR Report Key: 7464214
• MDR Text Key: 106707272
• Report Number: MW5076753
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other