MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-SYR W/NDLE,SAFETY,23GX1", 3ML

Model Number SYRS103235

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that, twice, the needle became loose from the syringe.No serious injury or adverse impact to a patient or 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, however, the reporting facility indicated that the needle-syringe connection issue occurred while the hypodermic needle was being used to extract fluid from a medication vial.This needle type is not designed to penetrate the rubber top of medication vials, but rather only for insertion into a patient.Blunt needles are suitable for this type of usage.The reported problem/issue was determined to have been caused by use error.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, twice, the needle became loose from the syringe.

• Type of Device: DBD-SYR W/NDLE,SAFETY,23GX1", 3ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 19056518
• MDR Text Key: 340346068
• Report Number: 1417592-2024-00246
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 40888277222572
• UDI-Public: 40888277222572
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SYRS103235
• Device Lot Number: 01105054
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other