MAUDE Adverse Event Report: NURSE ASSIST MONOJECT 10 ML; SALINE FLUSH

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 10/01/2015

Event Type  Injury  

Event Description

Reporter stated he is in a rehab center and was diagnosed with burkholderia cepacia from saline flushes he received.There is a recall from the fda and cdc for products received from nurse assist in (b)(6).Have been receiving flushes since (b)(6) 2016 for antibiotic treatment.

• Brand Name: MONOJECT 10 ML
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): NURSE ASSIST
• MDR Report Key: 6106069
• MDR Text Key: 60168054
• Report Number: MW5066074
• Device Sequence Number: 1
• Product Code: NGT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 111