MAUDE Adverse Event Report: SURE COMFORT; INSULIN SYRINGE

Catalog Number 22-6410

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/20/2019

Event Type  malfunction  

Event Description

The needle broke off in her skin.She was able to remove the needle with tweezers.

• Brand Name: SURE COMFORT
• Type of Device: INSULIN SYRINGE
• MDR Report Key: 16790753
• MDR Text Key: 313772377
• Report Number: 1000138447-2023-00002
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 22-6410
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/04/2019
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female