MAUDE Adverse Event Report: BD BD HEPARIN FLUSH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Skin Discoloration (2074)

Event Date 04/05/2018

Event Type  Injury  

Event Description

Pt utilizes a picc line.He had a routine bandage change on (b)(6) at a hospital.On (b)(6), the line was flushed with heparin at his home.On (b)(6) he went to the infusion center due to intense itching where the line was removed.Pt saw his primary care dr who prescribed an oral antibiotic and topical cream.He also experienced bicep discoloration and scaly dry skin and infection.His next pcp appt is on (b)(6) 2018.Situation to date remains unresolved.

• Brand Name: BD HEPARIN FLUSH
• Type of Device: HEPARIN FLUSH
• Manufacturer (Section D): BD
• MDR Report Key: 7525305
• MDR Text Key: 108668023
• Report Number: MW5077277
• Device Sequence Number: 0
• Product Code: NZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 49