Sex: F
Vaccine: FLU4
Symptoms: Exposure via breast milk, Occupational exposure to product, Product complaint, Skin laceration, Syringe issue
Clinical narrative: The syringe top where the plunger was located broke off; Nurse punctured her finger and suffered a minor cut due to broken Afluria pre-filled syringe; A certain amount of vaccine leaked on the nurse's finger; This is a spontaneous case initially received from other health professional via Med Communications (reference number: SEQ20-00727) on 25-Feb-2019, with additional information (being processed together) received on the same day (reference number: SEQ20-00726) concerning female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On 25-Feb-2020, while administering Afluria Quadrivalent (influenza vaccine; batch number: P100118969; expiration date: 30-Jun-2020), the syringe top where plunger was located broke off, punctured nurse's finger and she suffered a minor cut, so she discontinued to administer the vaccine. The reporter was not sure of the amount of vaccine which leaked on the nurse's finger. (explicitly coded as Syringe broken' and Occupational exposure via skin contact with product').  It was reported that according to the nurse there were no visible issues and the product was stored in the package syringes comes in, in the refrigerator. The syringe was removed from the box fright before administration and was not dropped.   Nurse was evaluated and assessed for her cut.   The outcome of event laceration of finger was not reported.  Product technical complaint (PTC) number 1054310 was assigned to this case.  Based on the Quality Assurance Investigation it was concluded that although a definitive root cause could be not determined as part of this investigation, there was no indication of a systemic manufacturing or syringe raw material defect.  A broken flange was unlikely attributed to a systemic manufacturing defect. On this basis, the final risk rating is Low'. Further, it was established that the raw materials were released in accordance with approved specifications and procedures. The continued supply presents no evident risk. The lot remains fit for continued use. The syringe barrel and broken flange was observed under microscope and no abnormalities or defects were observed. All retention samples inspected were deemed satisfactory. There were no damages noted on the transport.   This case is linked to 202001909 (same reporter).  Follow up information received from PTC group on 10-Apr-2020: Quality Assurance Investigation results were provided. The narrative was amended accordingly.   Follow up  was received from PTC group (reference number: 1054310) on 14-APR-2020: Quality Assurance Investigation Results were provided. The narrative was amended accordingly.  Company comment: The nurse was accidentally exposed to the product while administrating Afluria Quadrivalent to the patient. Reportedly, syringe broke off, punctured nurse's finger and vaccine leaked on the nurse's finger. Syringe issue is assessed as related, since adverse event associated with it was reported. Occupational exposure to product and skin laceration are assessed as not related to the suspect vaccine.; Sender's Comments: The nurse was accidentally exposed to the product while administrating Afluria Quadrivalent to the patient. Reportedly, syringe broke off, punctured nurse's finger and vaccine leaked on the nurse's finger. Syringe issue is assessed as related, since adverse event associated with it was reported. Occupational exposure to product and skin laceration are assessed as not related to the suspect vaccine.