MAUDE Adverse Event Report: MEDLINE EXCELSIOR; SYRINGE, 10ML SALINE IN 10ML

Model Number EMZE010001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

The reporting facility indicated that they were investigating fungal blood stream infections.No specific complaint was made that the emze010001 item caused or contributed to the infections, however, the reporting facility indicated that saline flushes were in use around the time of the infections.No information was provided on what other medical products were being used by the impacted patients around the time of the infections.To date, no information has been received to indicate that the emze010001 item did, in fact, cause or contributed to the reported infections.To date, no information has been received to indicate that a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the emze010001 item.No sample was returned for evaluation and no lot number has been provided.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

The reporting facility indicated that they were investigating fungal blood stream infections.

• Type of Device: SYRINGE, 10ML SALINE IN 10ML
• Manufacturer (Section D): MEDLINE EXCELSIOR; 1933 heck avenue; neptune NJ 07753 4428
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18826476
• MDR Text Key: 337583623
• Report Number: 2027791-2024-00009
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: EMZE010001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other