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

Model Number N/A

Device Problems Inaccurate Delivery (2339); Material Twisted/Bent (2981)

Patient Problems Nausea (1970); Vomiting (2144); Dizziness (2194); Decreased Appetite (4569)

Event Date 02/14/2022

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) nausea [nausea], vomiting [vomiting], dizziness [dizziness], could not eat anything [decreased appetite], needle came bent in the box [needle issue], patient was not sure if got full dose and administered another dose [device delivery system issue], patient was not sure if got full dose and administered another dose [extra dose administered], delivered 3 doses of 0.5 mg and then was empty [product packaging quantity issue].Case description: this serious spontaneous case from the united states was reported by a consumer as "nausea(nausea)" beginning on (b)(6) 2022, "vomiting(vomiting)" beginning on (b)(6)2022, "dizziness(dizziness)" beginning on (b)(6) 2022, "could not eat anything(appetite lost)" beginning on (b)(6) 2022, "needle came bent in the box(needle bent)" with an unspecified onset date, "patient was not sure if got full dose and administered another dose(inaccurate delivery by device)" with an unspecified onset date, "patient was not sure if got full dose and administered another dose(extra dose administered)" with an unspecified onset date, "delivered 3 doses of 0.5 mg and then was empty(package volume underfill)" with an unspecified onset date, and concerned a (b)(6) female patient who was treated with ozempic 0.25/0.50 mg (semaglutide) (dose, frequency & route used-0.5 mg, qw, subcutaneous) from unknown start date for "drug use for unknown indication", , novofine plus 4mm (32g) (needle) from unknown start date for "device therapy", medical history was not provided.On an unknown date, the patient receiving therapy with ozempic and novofine plus (32g) needles experienced that the needle bent, so patient was not sure if got full dose and administered another dose and on (b)(6) 2022, the patient got very sick clarified as nausea, vomiting, dizziness, could not eat anything.They could see the liquid inside and noticed the needle was bent only after taking the injection.The patient straightened the needle and administered another injection, got sick and vomited an hour later.As treatment, the patient drank a lot of water and ginger ale.Patient went to the urgent care and was treated with an intravenous.On the seventh day they still felt weak.It eventually ran its course.It was also reported that patient also reported pen only delivered 3 doses of 0.5 mg and then was empty.Batch numbers: ozempic 0.25/0.50 mg: lp59170, batch number of novofine plus 4mm (32g) requested.Action taken to ozempic 0.25/0.50 mg was not reported.On (b)(6) 2022 the outcome for the event "nausea(nausea)" was recovered.On (b)(6) 2022 the outcome for the event "vomiting(vomiting)" was recovered.On (b)(6) 2022 the outcome for the event "dizziness(dizziness)" was recovered.On (b)(6) 2022 the outcome for the event "could not eat anything(appetite lost)" was recovered.The outcome for the event "needle came bent in the box(needle bent)" was recovered.The outcome for the event "patient was not sure if got full dose and administered another dose(inaccurate delivery by device)" was not reported.The outcome for the event "patient was not sure if got full dose and administered another dose(extra dose administered)" was not reported.The outcome for the event "delivered 3 doses of 0.5 mg and then was empty(package volume underfill)" was not recovered.Ozempic 0.25/0.50 mg is a prefilled device.Current location of device: device not yet returned.Period of use: unknown, however use of ozempic 0.25/0.50 mg is ongoing.Preliminary manufacturer's comment: (b)(6) 2022: the suspected device novofine plus 4 mm (32g) has not been returned to novo nordisk for evaluation.No conclusion is reached.Considering that needle is bent, patient applied extra dose and experienced clinical events due to additional dose.

Event Description

Case description: action taken to novofine plus 4mm (32g) was not reported.Investigation result: ozempic® 0.25/0.5mg 1x1.5ml 6pcs nfpl - batch lp59170.The product was not returned for examination.If possible, please forward the reported product(s) for further investigations.The product was not returned for examination.If possible, please forward the reported product(s) for further investigations.A reference sample was examined macroscopically and analysed chemically.The reference sample was found to be normal.The results were found to comply with specifications.During investigation no irregularities related to the complaint was detected on a reference/reserve sample of the batch in question.The batch documentation, equipment logs and deviation (dv) were investigated and no abnormalities relating to the observed problem were found.Batch documentation was found to be normal.The batch documentation was reviewed and found to be normal.Novofine® plus 32g x 4mm - batch unknown.No investigation was possible, because neither sample nor batch number was available.If possible, please forward the reported product(s) for further investigations.Final manufacturer's comment: novofine plus needle.27-apr-2022: the suspected device (novofine plus 4mm (32g)) has not been returned to novo nordisk a/s for the investigation.Batch number of device is not available in spite of repeated efforts to get the same.Batch trend analysis or reference sample analysis not performed.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 4mm (32g).Considering that needle is bent, patient applied extra dose and experienced clinical events due to additional dose.Final manufacturer's comment: ozempic.27-apr-2022: the suspected device ozempic has not been returned to novo nordisk for evaluation.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.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 ozempic.The reported events could be attributed to extra dose administered.H3 continued: evaluation summary.Novofine® plus 32g x 4mm - batch unknown no investigation was possible, because neither sample nor batch number was available.If possible, please forward the reported product(s) for further investigations.

• Brand Name: NOVOFINE PLUS 4MM (32G)
• Type of Device: NEEDLE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd,, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd,, 2880 ; DA 2880
• Manufacturer Contact: p.o. box 846; plainsboro,, NJ 08536 ; 8007276500
• MDR Report Key: 13926276
• MDR Text Key: 288020219
• Report Number: 9681821-2022-00027
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K133738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

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 Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 185550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 04/20/2022
• Supplement Dates FDA Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Female