MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOFINE; NEEDLE

Catalog Number 185250

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Novofine needles (2) in her lower abdomen after they snapped off during separate injections [needle issue].Case description: does the incident represent a serious public health threat? no.This serious spontaneous case reported by a radiologist from the (b)(6) concerns a female pt (age not reported) who was treated with novofine (needle: type unspecified) on unk dates for device therapy and experienced "2 novofine needles in her lower abdomen after they snapped off during separate injections" beginning on an unk date.Pt's height: not reported.Med history: not reported.On an unk date it was noted that the pt had two novofine needles in her lower abdomen after they snapped off during separate injections.Action taken to novofine needle was not reported.The overall outcome of event was reported as unk.Note: as the needle gauge and length of suspected needle was not specified, novofine needle has been coded as the suspected product.

Manufacturer Narrative

• Brand Name: NOVOFINE
• Type of Device: NEEDLE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd ; DA
• Manufacturer (Section G): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd 2880 ; DA 2880
• Manufacturer Contact: novoprod ; p.o. box 846; plainsboro, NJ 08536 ; 6099875831
• MDR Report Key: 3876327
• MDR Text Key: 4568786
• Report Number: 9681821-2014-00025
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K861686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Type of Report: Initial
• Report Date: 01/08/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 185250
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2013
• 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): Other