MAUDE Adverse Event Report: MEDLINE EXCELSIOR; SYRINGE, STERILE, FIELD FLUSH 10 ML

Model Number EMZ10091280

Device Problem Material Fragmentation (1261)

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

Event Date 08/21/2019

Event Type  malfunction  

Event Description

It was reported that the end of the pre-filled syringe broke off while flushing.

Manufacturer Narrative

It was reported that the end of the pre-filled syringe broke off while flushing.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.Samples were returned for evaluation and the device involved in the incident was confirmed to have its tip broken.Testing of the three (3) additional syringes was performed and the problem/issue was unable to be duplicated.Testing of retained samples identified no defects.Based on the investigation performed, it was determined that the syringe was damaged prior to use, causing the tip to break upon use.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, STERILE, FIELD FLUSH 10 ML
• 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: 18954321
• MDR Text Key: 339212350
• Report Number: 2027791-2024-00037
• 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

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: EMZ10091280
• Device Lot Number: 3135994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Date Manufacturer Received: 08/21/2019
• 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