MAUDE Adverse Event Report: NOVO NORDISK A/S, MS HJOERRING NOVOFINE PLUS 4MM (32G); NEEDLE

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Event or Problem Description
Event verbatim [preferred term] (related symptoms if any separated by commas).Needle was in skin and, after a week the needle worked its way out [injury associated with device].Needles keep breaking and bending [needle issue].Case description: this serious spontaneous case from the united states was reported by a consumer as "needle was in skin and, after a week the needle worked its way out(injury associated with device)" with an unspecified onset date, "needles keep breaking and bending(needle broken)" with an unspecified onset date, and concerned a female patient who was treated with novofine plus 4mm (32g) (needle) from unknown start date for "type 2 diabetes mellitus", current condition: type 2 diabetes mellitus (duration not reported).Concomitant medications included - ozempic 0.25/0.50 mg (semaglutide 1.34 mg/ml) solution for injection.On an unknown date patient reported needle was in skin and did not know about it for a week or so to work its way out.It was scary to the patient.Additionally, patient reported needles kept breaking and bending, patient has to discard it.Batch numbers novofine plus 4mm (32g) was requested.Action taken to novofine plus 4mm (32g) was not reported.The outcome for the event "needle was in skin and, after a week the needle worked its way out (injury associated with device)" was unknown.The outcome for the event "needles keep breaking and bending (needle broken)" was unknown.Reporter's causality (novofine plus 4mm (32g)) - needle was in skin and, after a week the needle worked its way out (injury associated with device): unknown.Needles keep breaking and bending (needle broken): unknown.Company's causality (novofine plus 4mm (32g)) - needle was in skin and, after a week the needle worked its way out (injury associated with device): possible.Needles keep breaking and bending (needle broken): possible.

• Brand Name: NOVOFINE PLUS 4MM (32G)
• Common Device Name: NEEDLE
• Manufacturer (Section D): NOVO NORDISK A/S, MS HJOERRING; hjoerring,, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MS HJOERRING; stenager allé 4; hjoerring,, 9800 ; DA 9800
• Manufacturer Contact: p.o. box 846; plainsboro,, NJ 08536 ; 8007276500
• MDR Report Key: 22585542
• Report Number: 9681822-2025-00002
• Device Sequence Number: 14575019
• Product Code: FMI
• UDI-Device Identifier: 00301691855505
• UDI-Public: 00301691855505
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K133738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: 185550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OZEMPIC 0.25/0.50 MG (SEMAGLUTIDE 1.34 MG/ML).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female