MAUDE Adverse Event Report: NURSE ASSIST NURSE ASSIST 0.9 PERCENT USP SODIUM CHLORIDE INJECTION; NORMAL SALINE FLUSH, 1210

Lot Number 1607418

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

Product linked to b.Cepacia infection.

• Brand Name: NURSE ASSIST 0.9 PERCENT USP SODIUM CHLORIDE INJECTION
• Type of Device: NORMAL SALINE FLUSH, 1210
• Manufacturer (Section D): NURSE ASSIST; haltom city TX
• MDR Report Key: 6113298
• MDR Text Key: 60448109
• Report Number: MW5066137
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• 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