MAUDE Adverse Event Report: NURSE ASSIST NURSE ASSIST 0.9% USP SODIUM CHLORIDE INJECTION; NORMAL SALINE FLUSH

Lot Number 1607418

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 09/29/2016

Event Type  Injury  

Event Description

Product linked to b.Cepacia infection.

• Brand Name: NURSE ASSIST 0.9% USP SODIUM CHLORIDE INJECTION
• Type of Device: NORMAL SALINE FLUSH
• Manufacturer (Section D): NURSE ASSIST; halton city TX
• MDR Report Key: 6120460
• MDR Text Key: 60681451
• Report Number: MW5066223
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Lot Number: 1607418
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 93