MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOFINE 32G 6MM; NEEDLE

Catalog Number 185189

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Needle broke off during injection [needle issue].Case description: this serious spontaneous case from (b)(6) was reported by consumer as "needle broke off during injection" with an unspecified onset date, and concerned a female pt who was born on unk date in 1947 and was using with novofine 32g 6mm (needle) from an unk start date due to "device therapy".Pt's height, weight, body mass index were not reported.Medical history was not provided.It was reported that, the needle broke off during injection and the pt went to the hospital to get it removed.On an unk date, the broken off needle was removed in the hospital through surgery.Action taken to novofine 32g 6mm was not reported.The outcome for the event "needle broke off during injection" was not reported.No sample will be sent as pt has discarded the needles.

• Brand Name: NOVOFINE 32G 6MM
• Type of Device: NEEDLE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYS; brennum park; hilleroed 3400 ; DA 3400
• Manufacturer Contact: novo nordisk inc; po box 846; plainsboro, NJ 08536 ; 6099875831
• MDR Report Key: 3955157
• MDR Text Key: 4557524
• Report Number: 9681821-2014-00034
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K090111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Type of Report: Initial
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 185189
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention