MAUDE Adverse Event Report: HIGH-FLO SUB-Q SINGLE NEEDLE 26GX9MM; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/15/2019

Event Type  Injury  

Event Description

Spoke with pt's husband, (b)(6), who stated that pt did not receive supplies with last order.

• Brand Name: HIGH-FLO SUB-Q SINGLE NEEDLE 26GX9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 9349263
• MDR Text Key: 167383480
• Report Number: MW5091204
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 55555512609
• UDI-Public: 55555512609
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR