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

Model Number	N/A
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
(related symptoms if any separated by commas): swallowed unopened novofine plus 32g 4mm needle [accidental exposure to product].Swallowed unopened novofine plus 32g 4mm needle after accidentally mixing it with nightly medications [product appearance confusion].Case description: this serious spontaneous case from the united states was reported by a consumer as "swallowed unopened novofine plus 32g 4mm needle(accidental ingestion of product)" beginning on (b)(6) 2020, "swallowed unopened novofine plus 32g 4mm needle after accidentally mixing it with nightly medications(product appearance confusion)" beginning on (b)(6) 2020, and concerned a (b)(6) male patient who was treated with novofine 32g 4mm (needle) from unknown start date for "device therapy".Medical history was not provided.Concomitant products included - basaglar(insulin glargine).On (b)(6) 2020, the patient swallowed unopened novofine plus 32g 4mm needle after accidentally mixing it with nightly medications.The patient ate prunes and passed the pen needle through a bowel movement without seeking any additional medical attention.Batch numbers: novofine 32g 4mm: 19f02n.Action taken to novofine 32g 4mm was not reported.On (b)(6) 2020 the outcome for the event "swallowed unopened novofine plus 32g 4mm needle(accidental ingestion of product)" was recovered.On (b)(6) 2020 the outcome for the event "swallowed unopened novofine plus 32g 4mm needle after accidentally mixing it with nightly medications(product appearance confusion)" was recovered.Company comment: (b)(6) 2020: the elderly age of the patient ((b)(6)) is a significant risk factor for product appearance confusion and ingestion of needle by mistake.Relevant information on visual acuity, training on needle usage, and concomitant medications which look like novofine needles are unavailable for complete causality assessment.It could be an accidental incident.
Event or Problem Description
Case description: investigation result: name: novofine plus 32g x 4mm - batch 19f02n.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal.The product was not returned for examination.Since last submission the case has been updated with the following: investigation results updated.Company comment updated narrative updated accordingly.Company comment: (b)(6) 2020: the suspected device has not been returned to novo nordisk for evaluation.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The elderly age of the patient (69 years) is a significant risk factor for product appearance confusion and ingestion of needle by mistake.Relevant information on visual acuity, training on needle usage, and concomitant medications which look like novofine needles are unavailable for complete causality assessment.It could be an accidental incident.H3 continued: evaluation summary.Name: novofine plus 32g x 4mm - batch 19f02n.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal.The product was not returned for examination.

• Brand Name: NOVOFINE 4MM (32G)
• Common Device Name: NEEDLE
• Manufacturer (Section D): NOVO NORDISK A/S, MS HJOERRING; hjoerring, ; DA
• MDR Report Key: 10255307
• Report Number: 9681822-2020-00003
• Device Sequence Number: 2852934
• Product Code: FMI
• UDI-Device Identifier: 00301691855918
• UDI-Public: 00301691855918
• Combination Product (Y/N): N
• 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): 06/11/2020

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: 06/07/2024
• Device Model Number: N/A
• Device Catalogue Number: 185591
• Device Lot Number: 19F02N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 09/22/2020
• 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: BASAGLAR (INSULIN GLARGINE).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 DA