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

Catalog Number	16-SN3C2558S
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 1451040-2022-00054
• Device Sequence Number: 20299002
• Product Code: FMF
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2022
• Report Date (Section F): 10/05/2022

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
• Operator of Device: 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
• Distributor Facility Aware Date: 10/04/2022
• Device Age: 21 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/05/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/05/2022