MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYR W/NDLE,SAFETY,22GX1.5, 3ML

Model Number SSN103227Z

Device Problem Obstruction of Flow (2423)

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

Event Date 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that fluid would not flow out of the syringe.The reporting facility indicated, "it is like the hole was never board out in the needle." 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.Two (2) boxes of unused product were returned for evaluation and eighty (80) samples were randomly selected for visual inspection and functional testing.Visual inspection identified no manufacturing defects preventing the samples from working properly.Functional testing was performed by filling each syringe with 1ml of water and then dispensing the fluid into a cup.Each sample tested showed a continuous, uninterrupted flow of water.No blockage occurred and all needles had the proper hole to dispense liquid.The reported problem/issue was not confirmed and potential root cause was determined to be an issue with use of the item at the time of the incident.Due to the reported problem/issue, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that fluid would not flow out of the syringe.

• Type of Device: SYR W/NDLE,SAFETY,22GX1.5, 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: 18802974
• MDR Text Key: 337253028
• Report Number: 1417592-2024-00123
• Device Sequence Number: 1
• Product Code: MEG
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SSN103227Z
• Device Lot Number: 89722020002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other