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

Model Number 8881579121

Device Problem Material Fragmentation (1261)

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

Event Date 02/25/2019

Event Type  malfunction  

Event Description

It was reported that the tip of the syringe broke off.

Manufacturer Narrative

It was reported that the tip of the syringe broke off.Reportedly, this occurred "at the time of insertion." no serious injury or adverse impact to a user or a patient 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.Testing was performed on retained samples to determine if other syringes showed broken syringe tips or breakage upon experiencing stress.None of the retained samples exhibited the reported defect.A root cause was unable to be determined.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: DBD-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: 18951520
• MDR Text Key: 338261826
• Report Number: 2027791-2024-00019
• 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: 03/19/2024

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: 8881579121
• Device Lot Number: 3133499
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• 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