MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE-SYR W/NDLE,SAFETY,INSLN,1ML,29GX0.5"; SYRINGE, PISTON

Model Number SYRSI101292

Device Problems Fail-Safe Design Failure (1222); Component Missing (2306)

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

Event Date 06/04/2022

Event Type  malfunction  

Event Description

Registered nurse (rn) gave patient insulin.After injecting patient with insulin, rn attempted to employ the safety on the insulin needle.Rn realized there was no safety on insulin needle and therefore the only option was to recap it.The direction that the cap goes onto the needle is deceiving, it seems as if the needle should go into the incorrect end of the cap.This was an unsafe situation and rn was at risk of a needle stick multiple times throughout the process.

• Brand Name: MEDLINE-SYR W/NDLE,SAFETY,INSLN,1ML,29GX0.5"
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 14773587
• MDR Text Key: 294496952
• Report Number: 14773587
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYRSI101292
• Device Catalogue Number: SYRSI101292
• Device Lot Number: 89720120001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other