MAUDE Adverse Event Report: HIGH-FLO SUB-Q SINGLE NEEDLE 26GX9MM; SYRINGE, PISTON

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2020

Event Type  Injury  

Event Description

Syringe containing silicone may have been shipped with haegarda.

• Brand Name: HIGH-FLO SUB-Q SINGLE NEEDLE 26GX9MM
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 9729150
• MDR Text Key: 180611197
• Report Number: MW5093096
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 55555512609
• UDI-Public: 55555512609
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR