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

Catalog Number 16-N2558S

Device Problems Detachment of Device or Device Component (2907); 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 that the nurse experienced a needle completely bending while preparing a varicella vaccine.The needle subsequently dislodged and fell on the floor.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: 14078016
• MDR Text Key: 293634108
• Report Number: 1451040-2022-00013
• 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: 04/11/2022

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: 04/11/2022
• Distributor Facility Aware Date: 03/25/2022
• Device Age: 17 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other