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

Model Number	N/A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Local Reaction (2035); Injection Site Reaction (4562)
Type of Reportable Event	Serious Injury
Event or Problem Description
Event verbatim.Needle reusage; multiple use of single-use product.Left leg infection; localised infection.Possible blood clotting, thrombosis.Case description: study id: patient assistance program.Study description: the novo nordisk diabetes patient assistance program is a program for patients that qualify for financial assistance pursuant to financial guidelines as established by novo nordisk.Patients will be evaluated for the program against the criteria established by novo nordisk.This serious solicited report from the united states was reported by a consumer as "needle reusage(needle reusage)" with an unspecified onset date , "possible blood clotting(clot blood)" with an unspecified onset date , "left leg infection(leg infection)" with an unspecified onset date and concerned a male patient (born in 1953) who was treated with novofine 32g 4mm (needle) from unknown start date for "diabetes mellitus".Current condition: diabetes (type and duration was not reported).Concomitant medications included - tresiba flextouch u100(insulin degludec 100 iu/ml).Solution for injection, 100 iu/ml.On an unspecified date, the patient reported of reusing the needles.As a result the patient had an infection in the left leg with symptoms of pain and extreme swelling.As treatment the patient applied ice and elevated it.It was also suspected that the patient had possible blood clotting.A doppler reading test was done but results were not provided.On an unspecified date, patient's blood test and urine analysis were performed, results not reported.Batch number of novofine 32g 4mm was requested.Action taken to novofine 32g 4mm was not reported.The outcome for the event "needle reusage(needle reusage)" was not reported.The outcome for the event "possible blood clotting(clot blood)" was not reported.The outcome for the event "left leg infection(leg infection)" was unknown.Reporter's causality (novofine 32g 4mm) - needle reusage(needle reusage) : unknown.Possible blood clotting(clot blood) : unknown.Left leg infection(leg infection) : unknown.Company's causality (novofine 32g 4mm) - needle reusage(needle reusage) : possible.Possible blood clotting(clot blood) : unlikely.Left leg infection(leg infection) : unlikely.
Event or Problem Description
Case description: concomitant medications included - tresiba flextouch u100(insulin degludec 100 iu/ml) solution for injection, 100 iu/ml.Company comment: 07-mar-2022: the suspected device novofine 32g 4mm needle has not been returned to novo nordisk for evaluation.Reusing the needle could have contributed to localised infection at the injection site.No conclusion is reached.Since last submission the case has been updated with the following: -concomitant medication added.-narrative updated accordingly.
Event or Problem Description
Case description: concomitant medications included - tresiba flextouch u100(insulin degludec 100 iu/ml) solution for injection, 100 iu/ml, tresiba flextouch u200(insulin degludec) solution for injection, 200 iu/ml.Batch numbers: novofine 32g 4mm: 21j20n.Since last submission the case has been updated with the following: -batch number, manufacturing date and expiry date updated.-investigation result updated.-annex b, c, d, g codes updated.-narrative updated accordingly.Final manufacturer's comment: 02-may-2022: the suspected device (novofine plus 4mm (32g)) has not been returned to novo nordisk a/s for the investigation.Batch number of devices is available now.Batch trend analysis or reference sample analysis will be performed.No confounding factors identified.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).Reusing the needle could have contributed to localised infection at the injection site.Manufacturing site is confirmed with batch number to be 9681822, report 9681821-2022-00028 will be further reported under 9681822-2022-00001.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 32G 4MM
• Common Device Name: 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: 13927448
• Report Number: 9681821-2022-00028
• Device Sequence Number: 19280133
• Product Code: FMI
• UDI-Device Identifier: 00301691858506
• UDI-Public: 00301691858506
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Study,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/27/2026
• Device Model Number: N/A
• Device Catalogue Number: 185850
• Device Lot Number: 21J20N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 04/04/2022; 04/25/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/21/2022; 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRESIBA FLEXTOUCH U100; TRESIBA FLEXTOUCH U100; TRESIBA FLEXTOUCH U100 INSULIN DEGLUDEC 100 IU/ML; TRESIBA FLEXTOUCH U100 INSULIN DEGLUDEC 100 IU/ML; TRESIBA FLEXTOUCH U200
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male