MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOFINE 32G 6 MM; NEEDLE

Model Number	N/A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Hears a whistling sound when taking a deep breath [breath sounds abnormal].Accidentally inhaled or swallowed inner needle cap [foreign body aspiration].Case description: this serious spontaneous case from the united states was reported by a consumer as "hears a whistling sound when taking a deep breath (breath sounds abnormal)" beginning on (b)(6) 2019, "accidentally inhaled or swallowed inner needle cap(foreign body aspiration)" beginning on (b)(6) 2019, and concerned a (b)(6) male patient who was treated with novofine 32g 6 mm (needle) from unknown start date and ongoing for "type 2 diabetes mellitus".Current condition: type 2 diabetes mellitus (duration not reported).Concomitant products included - novolog flexpen(insulin aspart) solution for injection, 100 u/ml on (b)(6) 2019, the patient intentionally bit the inner needle cap off and accidentally inhaled and swallowed the cap.As a result, the patient hear a whistling sound when taking a deep breath.Batch numbers: novofine 32g 6 mm: 18a11k.Action taken to novofine 32g 6 mm was reported as no change.The outcome for the event "hears a whistling sound when taking a deep breath(breath sounds abnormal)" was not recovered.The outcome for the event "accidentally inhaled or swallowed inner needle cap(foreign body aspiration)" was not reported.
Event or Problem Description
Case description: patient's weight, height and body mass.Current condition: type 2 diabetes mellitus.Investigation results: name: novofine 32g tip 6mm with batch number: 18a11k.The product was not returned for examination.The batch documentation was reviewed.No abnormalities relating to the observed problem was found.A visual examination of the product was performed.For novofine 32g x 6mm carton 8-4304-31-301-4 as per complaint description where there is no information about how the inner needle cap has to be removed.Since last submission the case has been updated with the following information: -investigational results updated.-manufacturers comment updated.Narrative updated accordingly.Manufacturer's comment: on 04-feb-2020: the device (novofine 32g 6 mm) has not been returned to novo nordisk a/s for investigation.However, the user did intentionally bit the inner needle cap off during which the patient accidentally inhaled and swallowed the cap resulting in whistling sound when taking a deep breath.H3 continued: evaluation summary: name: novofine 32g tip 6mm with batch number: 18a11k.The product was not returned for examination.The batch documentation was reviewed.No abnormalities relating to the observed problem was found.A visual examination of the product was performed.For novofine 32g x 6mm carton 8-4304-31-301-4 as per complaint description where there is no information about how the inner needle cap has to be removed.

• Brand Name: NOVOFINE 32G 6 MM
• Common Device Name: NEEDLE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd, ; DA
• MDR Report Key: 9376458
• Report Number: 9681821-2019-00079
• Device Sequence Number: 2258066
• Product Code: FMI
• UDI-Device Identifier: 00301691851897
• UDI-Public: 00301691851897
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K090111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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: 12/01/2022
• Device Model Number: N/A
• Device Catalogue Number: 185189
• Device Lot Number: 18A11K
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 02/27/2020
• 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: NOVOLOG FLEXPEN (INSULIN ASPART)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR