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

Model Number EMZE010001

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that medication leaked around the stopper of the pre-filled syringe plunger after the flush was used to mix an unspecified antibiotic.No serious injury or adverse impact to a patient or to a user was originally reported.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.No photo or sample were provided for evaluation.Retention samples were evaluated to determine if other syringes from the reported lot experienced leakage and no defects were identified.The root cause was determined to be use error as labeling and instructions for use indicate that the device is for "iv flush only" and that "saline flush syringes are not for use for reconstitution or dilution of medication." 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

It was reported that medication leaked around the stopper of the pre-filled syringe plunger.

• 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: 18954323
• MDR Text Key: 338334878
• Report Number: 2027791-2024-00043
• 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: 03/20/2024

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
• Device Lot Number: 3137204
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 03/21/2024
• 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