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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Accidental needle stick with potential (b)(6) transmission [injury associated with device].Case description: this serious spontaneous case from the united states was reported by a nurse as "accidental needle stick with potential (b)(6) transmission" beginning on (b)(6) 2019, "accidental needle stick with potential (b)(6) transmission" beginning on (b)(6) 2019, and concerned a (b)(6) female patient who was treated with novofine 8mm (30g) autocover (needle) from unknown start date due to "device therapy".Medical history was not provided.Concomitant products included - byetta (exenatide, exenatide) on (b)(6) 2019.The patient accidentally stuck herself with novofine autocover needle after administering byetta to a patient with (b)(6).The patient stuck herself with the part of the needle that went into the byetta.Action taken to novofine 8mm (30g) autocover was not reported.Batch number was reported.The outcome for the event "accidental needle stick with potential (b)(6) transmission" was not reported.
Event or Problem Description
Case description: investigation results: novofine autocover 30g 100 needles, batch number: 18j14u: the product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.Since last submission the case was updated with the following: investigation results were updated, manufacturer comment updated, narrative updated accordingly.Manufacturer comment: 28-mar-2019: as the device (novofine 8mm) has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in argus case (b)(4).Evaluation summary: novofine autocover 30g 100 needles, batch number: 18j14u: the product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.

• Brand Name: NOVOFINE 8MM (30G)AUTOCOVER
• Common Device Name: NEEDLE
• Manufacturer (Section D): NOVO NORDISK A/S, MS HJOERRING; hjoerring, ; DA
• MDR Report Key: 8421894
• Report Number: 9681822-2019-00002
• Device Sequence Number: 277665
• Product Code: FMI
• UDI-Device Identifier: 00301691852757
• UDI-Public: 00301691852757
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K050106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2019

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: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 185275
• Device Lot Number: 18J14U
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/24/2019
• 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: BYETTA (EXENATIDE, EXENATIDE)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 YR