MAUDE Adverse Event Report: UNKNOWN BUTTERFLY NEEDLE INF ST 2100 U; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Event Description

Patient has trouble injecting and wants bigger needles.No specifies provided regarding whether or not the patient missed any doses or experienced any adverse events.Unknown if the needles patient is referring to are on hand.Reported to (b)(6) by: patient/caregiver.

• Brand Name: BUTTERFLY NEEDLE INF ST 2100 U
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8760748
• MDR Text Key: 150366591
• Report Number: MW5087884
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1