MAUDE Adverse Event Report: EXCELSIOR MEDICAL LLC 10ML SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Model Number EMZE010001

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

Event Date 09/25/2023

Event Type  malfunction  

Event Description

10ml 0.9% sodium chloride injection, usp "zr flush" syringe attached to stopcock on med-line of picc line.Unable to fully thread/lock sodium chloride syringe to stopcock.Syringe replaced with a separate 10ml 0.9% sodium chloride injection usp syringe which was able to be fully threaded and lock into place on stopcock.Product saved.Manufacturer: excelsior medical product name: 0.9% sodium chloride injection, usp product, lot number: 3142652.

• Brand Name: 10ML SALINE SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): EXCELSIOR MEDICAL LLC; 1933 heck ave; neptune NJ 07753
• MDR Report Key: 18354777
• MDR Text Key: 330874193
• Report Number: 18354777
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/12/2023

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 Operator: Other
• Device Model Number: EMZE010001
• Device Lot Number: 3142652
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other