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

Model Number	N/A
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Injection Site Reaction (4562)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Whelps- very painfulness at the injection site [injection site pain], patient does not like the novofine plus 32 g needle [needle issue].Case description: this serious spontaneous case from the united states was reported by a consumer as "whelps- very painfulness at the injection site(injection site pain)" beginning on (b)(6) 2020, "patient does not like the novofine plus 32 g needle(needle issue)" beginning on (b)(6) 2020, and concerned a elderly female patient who was treated with novofine plus 4mm (32g) (needle) from (b)(6) 2020 for "device therapy".Medical history was not provided.Concomitant products included - tresiba flextouch u200 (insulin degludec) solution for injection, 200 u/ml --/--/2018 to unk.On an unspecified date in (b)(6) 2020, the patient reported that injections were very painful at the injection site and patient did not like the novofine plus 32g needle.Batch numbers: novofine plus 4mm (32g): 20c04n.Action taken to novofine plus 4mm (32g) was not reported.The outcome for the event "whelps- very painfulness at the injection site (injection site pain)" was recovered.The outcome for the event "patient does not like the novofine plus 32 g needle (needle issue)" was recovered.References included: reference type: sims case number reference id#: (b)(4).Reference notes: reference type: sims case number reference id#: (b)(4).Reference notes.
Event or Problem Description
Case description: investigational results: novofine® plus 32g x 4mm (batch number: 20c04n).Microscopic examination performed.Needle points on patient needles examined visually for defects.Needles tested for silicone on patient needle.The product was found to be normal.The results were found to comply with specifications.During test it has not been possible to detect any irregularities related to the complaint on the unused needles.Since last submission, the case has been updated with the following: -investigational results for novofine needle updated; -imdrf codes annex b, c and d updated; -narrative updated accordingly.Final manufacturer's comment: 24-nov-2020: since no faults were found on the returned device novofine plus needles (batch no.20c04n) and only very limited information regarding the patients handling of the suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event.Injection site pain is possible with novofine plus needle as pain is subjective.It could be related to incorrect handling of the product.H3 continued: evaluation summary; novofine® plus 32g x 4mm : batch 20c04n; microscopic examination performed.Needle points on patient needles examined visually for defects.Needles tested for silicone on patient needle.The product was found to be normal.The results were found to comply with specifications.During test it has not been possible to detect any irregularities related to the complaint on the unused needles.

• Brand Name: NOVOFINE PLUS 4MM (32G)
• Common Device Name: NEEDLE
• Manufacturer (Section D): NOVO NORDISK A/S, MS HJOERRING; hjoerring, ; DA
• MDR Report Key: 10706987
• Report Number: 9681822-2020-00007
• Device Sequence Number: 3229036
• Product Code: FMI
• UDI-Device Identifier: 00301691855505
• UDI-Public: 00301691855505
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 09/21/2020

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: 03/11/2025
• Device Model Number: N/A
• Device Catalogue Number: 185550
• Device Lot Number: 20C04N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRESIBA FLEXTOUCH U200.
• Outcome Attributed to Adverse Event: Other