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

Model Number EMZE010001

Device Problem Connection Problem (2900)

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

Event Date 04/02/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the syringe was "easy to overturn" when attaching to the needleless connector of a high pressure system, which was resulting in syringe detachment, and that air bubbles were difficult to expel.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problems/issues.No sample was returned for evaluation and no lot number was provided.Representative sample testing using product of the same model number was performed and the reported overturning issue could not be confirmed.A root cause investigation determined that the issue reported was the result of user error in the form of improper technique, as overtightening a syringe onto a needleless connector requires excess force, approximately 5x that which is required to properly secure a syringe.The reporting facility followed up with the manufacturer related to the reported difficulty with expelling air bubbles and they indicated it was determined to have been due to a use issue as they had recently converted from a different manufacturer's product.Due to the reported product problems/issues, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the syringe was "easy to overturn" and that air bubbles were difficult to expel.

• 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: 18730262
• MDR Text Key: 336748785
• Report Number: 2027791-2024-00003
• 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: 02/19/2024

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: 04/02/2020
• Initial Date FDA Received: 02/19/2024
• 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