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

Model Number EMZ111240

Device Problem Connection Problem (2900)

Patient Problem Exposure to Body Fluids (1745)

Event Date 02/27/2020

Event Type  malfunction  

Event Description

It was reported that the syringe "popped off" during use.

Manufacturer Narrative

It was reported that the syringe "popped off" during use.The reporting facility indicated that the syringe was being used for "aspiration" at the time of the reported disconnection and that staff members were exposed to "splashing blood." 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 problem/issue.The reporting facility provided the needleless connectors that they typically used, however, no syringe sample was returned.Testing was performed using syringes from stock.When the syringes were fully engaged with the facility's needleless connectors, no disconnection was noted.In the event that a syringe is not fully engaged to a connector, disconnection may occur.Additionally, instructions for this item indicate it is for "for iv flush only" and the reporting facility was improperly using the item for aspiration.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.

• Type of Device: SYRINGE, 10ML SALINE IN 10ML
• Manufacturer (Section D): MEDLINE EXCELSIOR; 1933 heck drive; neptune NJ 07753 4428
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18865271
• MDR Text Key: 337690490
• Report Number: 2027791-2024-00048
• 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: 03/06/2024

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: EMZ111240
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/08/2024
• 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