MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE 25 G X 5/8IN

Catalog Number 402558

Device Problems Fail-Safe Problem (2936); Material Twisted/Bent (2981)

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

Event Date 05/10/2023

Event Type  malfunction  

Event Description

When opening the needle package to draw up the patient's medication there was a second needle bent upwards posing a sharp injury risk.

• Brand Name: HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE 25 G X 5/8IN
• Type of Device: HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE 25 G X 5/8IN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 17125210
• MDR Text Key: 317141005
• Report Number: 17125210
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/19/2023

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 Catalogue Number: 402558
• Device Lot Number: 4347189
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Sex: Female