MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOFINE 8MM (30G); NEEDLE

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problem Injection Site Reaction (4562)

Event Date 05/09/2023

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Erythema appeared at the puncture site [injection site erythema].Skin damage(injection site) [injection site injury].Puncture site slight bleeding [injection site haemorrhage].Mild pain during injection [injection site pain].The needle tip was slightly bent, there was a small hairy hook at the tip of the needle [needle issue].Doctor immediately instructed the patient to stop using this batch of insulin needles [product quality issue].Case description: this serious spontaneous case received via regulatory authority via national medical product administration (nmpa) from china was reported by a health care professional as "erythema appeared at the puncture site(injection site erythema)" beginning on (b)(6) 2023, "skin damage(injection site)(injection site injury)" beginning on (b)(6) 2023, "puncture site slight bleeding(injection site bleeding)".Beginning on (b)(6)2023, "mild pain during injection(injection site pain)".0 beginning on (b)(6) 2023, "the needle tip was slightly bent, there was a small hairy hook at the tip of the needle(needle bent)" beginning on (b)(6) 2023, "doctor immediately instructed the patient to stop using this batch of insulin needles(product lot specific issue)" with an unspecified onset date, and concerned a 68 years old male patient who was treated with novofine 8mm (30g) (needle) from (b)(6) 2023 for "device therapy".Patient's height, weight and body mass index (bmi) was not reported.Dosage regimens: novofine 8mm (30g): (b)(6) 2023 to not report; medical history was not provided.Concomitant products included - levemir penfill(insulin detemir) solution for injection,.0024 mol/l, novorapid penfill(insulin aspart) solution for injection, 100 iu/ml.On (b)(6) 2023, the patient purchased two pieces of insulin detemir injection (pelfill) (novo nordisk) and specialized needles for nn insulin syringe in this batch from the hospital.At 14:00 on the same day, according to the doctor's prescription, the patient used the syringe mounted with an insulin needle of this batch to inject insulin into the injection site.After the injection, the patient felt good.After 5 minutes, the patient had mild pain at the injection site.The patient immediately observed the injection site and found erythema at the puncture site, skin damage, and slight bleeding.The patient immediately came to the hospital to consult with the doctor.The therapeutic effect was good during the treatment process.After inquiring about the patient's basic situation before and after use of medication, the clinical doctor observed the needle used by the patient and found that there was a small hairy hook at the tip of the needle, which caused damage to the patient's skin and slight bleeding and pain during injection.The clinical doctor immediately instructed the patient to stop using this batch of insulin needles and provided the patient with another batch of insulin needles.After disinfecting the patient's affected part and performing simple antibacterial treatment, the doctor gave the patient relevant oral medication(unspecified).After telling the patient matters needing attention, the patient left.The next day, the clinical doctor called the patient for follow up, and the patient told that after changing to another batch of needles, the above discomfort symptoms did not occur again, and the above symptoms were alleviated.Batch numbers: novofine 8mm (30g): 21a07y.Action taken to novofine 8mm (30g) was reported as product discontinued due to ae.The outcome for the event "erythema appeared at the puncture site(injection site erythema)" was recovering/resolving.The outcome for the event "skin damage(injection site)(injection site injury)" was recovering/resolving.The outcome for the event "puncture site slight bleeding(injection site bleeding)" was recovering/resolving.The outcome for the event "mild pain during injection(injection site pain)" was recovering/resolving.The outcome for the event "the needle tip was slightly bent, there was a small hairy hook at the tip of the needle(needle bent)" was not reported.The outcome for the event "doctor immediately instructed the patient to stop using this batch of insulin needles(product lot specific issue)" was not reported.No further information available.References included: reference type: e2b authority number.Reference id#: cn-nmpa-1376104112023000024.Reference notes: affiliate reference number.Preliminary manufacturer's comment: 18-aug-2023: the suspected device novofine 8mm (30 g) has not been returned to novo nordisk for evaluation.Relevant information on training from hcp on handling of devices, storage, reusage and technical complaint or malfunction with drug delivery devices are unavailable for complete causality assessment.

Event Description

Case description: investigational result: novofine® 30g 0.3*8mm, batch number: 21a07y.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.The batch documentation has been reviewed and found to be normal.No abnormalities relating to the observed problem were found.Since last submission the case has been updated with the following: investigation result added.Imdrf code added.Relevant fields updated in eu/ca tab.Narrative updated accordingly.Final manufacturer's comment: 27-sep-2023: the suspected device novofine 8mm (30 g) 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 novofine needle.Considering the nature of events, route of administration being subcutaneous, the reported injection site reactions could be attributed incorrect product handling.H3 continued: evaluation summary novofine 30g 0.3*8mm, batch number: 21a07y.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.The batch documentation has been reviewed and found to be normal.No abnormalities relating to the observed problem were found.

• Brand Name: NOVOFINE 8MM (30G)
• 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: 17717922
• MDR Text Key: 323046609
• Report Number: 9681821-2023-00127
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K861686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

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 Lot Number: 21A07Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LEVEMIR PENFILL (INSULIN DETEMIR); NOVORAPID PENFILL (INSULIN ASPART)
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male