MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. MCKESSON BRANDS; SYRINGE/NDL, SAFETY PREVENT HT3CC 25GX5/8"

Catalog Number 16-SN3C2558S

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 10/04/2022

Event Type  malfunction  

Event Description

The customer reported that they have had multiple needles break off in the vials when drawing up vaccines and they are bending after administering the shots as well.In one case, the needle bent after removing it from the patient's arm.No information was received regarding any type of serious injury as a result of this product malfunction.

• Brand Name: MCKESSON BRANDS
• Type of Device: SYRINGE/NDL, SAFETY PREVENT HT3CC 25GX5/8"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; moliver@sol-m.com; lawrenceville GA 30043
• MDR Report Key: 15542737
• MDR Text Key: 301167786
• Report Number: 1451040-2022-00054
• Device Sequence Number: 1
• Product Code: FMF
• 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: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16-SN3C2558S
• Device Lot Number: CSOA01-03
• 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: 10/05/2022
• Distributor Facility Aware Date: 10/04/2022
• Device Age: 21 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1