MAUDE Adverse Event Report: BD PRE-FILLED HEPARIN FLUSH SYRINGE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Device Problem Microbial Contamination of Device (2303)

Patient Problems Erythema (1840); Unspecified Infection (1930); Swelling (2091); No Code Available (3191)

Event Date 11/20/2017

Event Type  Injury  

Event Description

Pt stated within two weeks of using saline solution, she developed an infection.Pt reported watery bloody returns.Towards the end of (b)(6) 2017 the site of picc line was red and swollen.Picc line was taken out (b)(6) 2017.Pt had to take 10 days of antibiotic after picc line removal.

• Brand Name: PRE-FILLED HEPARIN FLUSH SYRINGE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD
• MDR Report Key: 7525304
• MDR Text Key: 108693454
• Report Number: MW5077276
• 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 Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: HEPARIN: (B)(4)
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 118