Sex: F
Vaccine: HIBV
Symptoms: Device connection issue, Exposure via skin contact, Injury associated with device
Clinical narrative: Hiberix was being given to an infant when the needle popped off and stuck in the infants left leg; skin exposure/ vaccine splattered all over the infant's leg; Once the medication was being pushed in the infants leg it splattered all over the infant leg; entire Luer Lock Adaptor and attached needle pop off the end of the prefilled syringes; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental needle stick in a 2-month-old female patient who received Hib (Hiberix) (batch number T2AG9) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix (intramuscular, left thigh). On an unknown date, immediately after receiving Hiberix, the patient experienced accidental needle stick (Verbatim: Hiberix was being given to an infant when the needle popped off and stuck in the infants left leg), exposure via skin contact (Verbatim: skin exposure/ vaccine splattered all over the infant's leg), inadvertent exposure to vaccine (Verbatim: Once the medication was being pushed in the infants leg it splattered all over the infant leg), syringe connection issue (Verbatim: entire Luer Lock Adaptor and attached needle pop off the end of the prefilled syringes) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental needle stick was resolved and the outcome of the exposure via skin contact, inadvertent exposure to vaccine, syringe connection issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the accidental needle stick to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device.     It was unknown if the company considered the accidental needle stick to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-APR-2024 and 24-APR-2024 The medical assistant reported a product complaint with related adverse events. When the nurse was administering dose the entire luer lock adaptor and attached needle pop off the end of the prefilled syringes. Hiberix was being given to an infant when the needle popped off and stuck in the infant (patient) left leg. Once the medication was being pushed in the infant leg it splattered all over the infant's leg, which led to exposure via skin contact and inadvertent exposure to vaccine.  The reporter did confirm there was no damage due to shipping. Confirmation that all operations were performed appropriately before defect was discovered. The defect was discovered during administration. The mixing/shaking was done by gently shaking. The vial held upside-down when the vaccine was being withdrawn. The dose was not administered. However, the neck with the needle came off and stuck in infant left thigh. The HCPs (health care professionals) who preparing/administering vaccine were experienced users. The luer lock adaptor was the component impacted. The safety needle 25G 5/8 Luer Lock used. There was not any defect or damage on the syringe noticed. When removing the cap, it was screwed off. The needle was screwed on the Luer Lock device. The needle, which was used, was not available, it was placed in the sharp's container, however, there was a picture being sent to GlaxoSmithKline.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024052005:AE1/2 different infant