MAUDE Adverse Event Report: NOVO NORDISK, INC. NOVOFINE AUTOCOVER NEEDLES; NEEDLE, HYPODERMIC, SINGLE LUMEN

Device Problem Difficult to Open or Close (2921)

Patient Problem Missed Dose (2561)

Event Date 01/20/2010

Event Type  Injury  

Event Description

The novofine autocover needles were sent and mom said that she couldn¿t get the inner needle cover off.Advised her that the inner needle cover does not come off.Advised her that the inner needle cover does not come off with the autocover.Mother decided that she would prefer different pen needles, so i advised patient that i will get different one sent out to her that do not have the autocover.Ae submitted- patient has still not been able to receive any norditropin injections.

• Brand Name: NOVOFINE AUTOCOVER NEEDLES
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): NOVO NORDISK, INC.
• MDR Report Key: 9632120
• MDR Text Key: 176663764
• Report Number: MW5092501
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• 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?: No
• Patient Sequence Number: 1
• Patient Age: 23 MO