MAUDE Adverse Event Report: SYRINGE NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 210630

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/04/2022

Event Type  malfunction  

Event Description

Spontaneous communication from patient states 2 different syringe needles bent when trying to administer the injection.Patient is also unable to inject the medications using the whisperject device.Malfunction date (b)(6) 2022.No adverse event was reported.No missed dose reported.Unknown if patient has defective product on hand.No further information.Reported to (b)(6) by pt/caregiver.

• Brand Name: SYRINGE NEEDLE
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• MDR Report Key: 14397304
• MDR Text Key: 291716239
• Report Number: MW5109668
• Device Sequence Number: 1
• Product Code: KZH
• 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: 05/09/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/31/2023
• Device Model Number: 210630
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2022
• Patient Sequence Number: 1
• Treatment: GLATIRAMER ACETATE (12X1ML)
• Patient Age: 69 YR
• Patient Sex: Male