MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. MCKESSON BRANDS; NEEDLE, SAFETY PREVENT HT 25GX5/8"

Catalog Number 16-N2558S

Device Problems Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)

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

Event Date 03/25/2022

Event Type  malfunction  

Event Description

It was reported by the nurse that the needle bent outside the engaged safety device when disposing of the used needle.No information was received regarding any type of serious injury as a result of this product malfunction.

• Brand Name: MCKESSON BRANDS
• Type of Device: NEEDLE, SAFETY PREVENT HT 25GX5/8"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; moliver@sol-m.com; lawrenceville GA 30043
• MDR Report Key: 14085615
• MDR Text Key: 293633978
• Report Number: 1451040-2022-00014
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2022

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 Catalogue Number: 16-N2558S
• Device Lot Number: CS0J10-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2022
• Distributor Facility Aware Date: 03/25/2022
• Device Age: 17 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/12/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other