MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DBD-SYRINGE, STERILE, FIELD FLUSH 10 ML

Catalog Number EMZ10091240

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 10/03/2022

Event Type  Death  

Manufacturer Narrative

It was reported by the customer contact that on (b)(6) 2022, "my mother passed away from the unsterile medline saline products used for months leading up to her death recalled from the nurse assist report on 2023.Had all the life threatening affects associated with the report." after further investigation it was determined that based on the material and data provided (sterilization data and fmea), there was not conclusive evidence that this device caused the patient to expire.The device was not available for return evaluation.It has been determined that the reported event caused or contributed to serious injury.This is a reportable event.If additional information becomes available this report will be reopened and reevaluated.

Event Description

"unsterile medline saline.".

• Type of Device: DBD-SYRINGE, STERILE, FIELD FLUSH 10 ML
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18514913
• MDR Text Key: 332868639
• Report Number: 1417592-2024-00027
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: EMZ10091240
• Device Lot Number: 22073679
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death