MAUDE Adverse Event Report: MEDLINE EXCELSIOR; SYRINGE, 5ML SALINE IN 10ML

Catalog Number EMZ151240Z

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 04/21/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that the syringes have "cracks" and are "leaking".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.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on (b)(6) 2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the syringes have "cracks" and are "leaking".

• Type of Device: SYRINGE, 5ML SALINE IN 10ML
• Manufacturer (Section D): MEDLINE EXCELSIOR; 1933 heck avenue; neptune NJ 07753
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18856117
• MDR Text Key: 337186853
• Report Number: 2027791-2024-00054
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00363807000056
• UDI-Public: 00363807000056
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EMZ151240Z
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other