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 Codes	Device Embedded In Tissue or Plaque (3165); Injection Site Reaction (4562)
Type of Reportable Event	Serious Injury
Event or Problem Description
Event verbatim [preferred term] (related symptoms if any separated by commas).Needle broke inside skin at injection site [needle issue].Needle broke inside skin at injection site [injection site injury].Needle broke inside skin at injection site [injury associated with device].This serious spontaneous case from the united states was reported by a consumer as "needle broke inside skin at injection site(needle broken)" with an unspecified onset date, "needle broke inside skin at injection site(injection site injury)" with an unspecified onset date, "needle broke inside skin at injection site(needle stick/puncture)" with an unspecified onset date, and concerned a adult female patient (born in 1951) who was treated with novofine plus 4mm (32g) (needle) from unknown start date for "device therapy".Medical history was not provided.On an unspecified date, the patient reported that the needle broke at injection site and was still stuck in skin.Batch numbers: novofine plus 4mm (32g): 20f13n.Action taken to novofine plus 4mm (32g) (needle) was not reported.The outcome for the event "needle broke inside skin at injection site(needle broken)" was recovered.The outcome for the event "needle broke inside skin at injection site(injection site injury)" was recovered.The outcome for the event "needle broke inside skin at injection site(needle stick/puncture)" was recovered.Investigation result: novofine plus (32g) batch number:20f13n.The product was not returned for examination.Microscopic examination performed.A visual examination of the back needle of the reference sample was performed.The needles were tested for flow with measure threads.Needles tested for silicone on patient needle.Needle points on patient needles examined visually for defects.An examination of a reference sample showed nothing abnormal.During investigation no irregularities related to the complaint was detected on a reference sample of the batch in question.References included: reference type: e2b linked report.Reference id#: (b)(4).Reference notes: same reporter, similar event.Final manufacturer's comment: 12-jun-2021: the suspected device (novofine plus 32g) has not been returned to novo nordisk a/s for the investigation.The batch trend analysis and reference sample examination revealed nothing abnormal.No abnormalities relating to the observed problem were found.With the available limited information regarding the handling of the suspected device, it is not possible to identify a clear root cause in relation to functionality of novofine plus 32g.Elderly age of the patient is a risk factor for needle injury as the skin is more fragile in older patients.Evaluation summary: novofine plus (32g) batch number:20f13n.The product was not returned for examination.If possible, please forward the reported product(s) for further investigations.Microscopic examination performed.A visual examination of the back needle of the reference sample was performed.The needles were tested for flow with measure threads.Needles tested for silicone on patient needle.Needle points on patient needles examined visually for defects.An examination of a reference sample showed nothing abnormal.During investigation no irregularities related to the complaint was detected on a reference sample of the batch in question.

• Brand Name: NOVOFINE PLUS 4MM (32G)
• Common Device Name: NEEDLE
• Manufacturer (Section D): NOVO NORDISK A/S, MS HJOERRING; hjoerring,, ; DA
• MDR Report Key: 12030775
• Report Number: 9681822-2021-00006
• Device Sequence Number: 11803831
• Product Code: FMI
• UDI-Device Identifier: 00301691855505
• UDI-Public: 00301691855505
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 05/24/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/17/2025
• Device Model Number: N/A
• Device Catalogue Number: 185550
• Device Lot Number: 20F13N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other