Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Device connection issue, Needle issue, Underdose
Clinical narrative: difficult to attach the needle to the luer lock device, and when was finally attached, the needle in all cases were loose; the needle detached during the administration/ needle was loose; doctor was well trained, and she was the one who informed reporter about the faulty syringe; Product Complaint; vaccine was administered partially to patient/ the needle detached during the administration, missing part of the vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 2-month-old female patient who received Hib (Hiberix) (batch number Y24T9, expiry date 14-MAR-2026) for prophylaxis. This case was associated with a product complaint.   On 17-APR-2024, the patient received Hiberix. On 17-APR-2024, an unknown time after receiving Hiberix, the patient experienced accidental underdose (Verbatim: vaccine was administered partially to patient/ the needle detached during the administration, missing part of the vaccine). On an unknown date, the patient experienced device connection issue (Verbatim: difficult to attach the needle to the luer lock device, and when was finally attached, the needle in all cases were loose), needle issue (Verbatim: the needle detached during the administration/ needle was loose), syringe issue (Verbatim: doctor was well trained, and she was the one who informed reporter about the faulty syringe) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental underdose, device connection issue, needle issue, syringe issue and pharmaceutical product complaint were unknown.   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: 19-APR-2024  A pediatric office manager reported that they had issues with some prefilled syringes for Hiberix.  According to the reporter the issue happened to 8 prefilled syringes, the defect was discovered after the reconstitution and in all cases, vaccines were administered.  The reporter stated that it was difficult to attach the needle to the luer lock device, and when was finally attached, the needle in all cases were loose, which led to device connection issue. The vaccine was administered partially to the patient (infant patient), the needle detached during the administration, missing part of the vaccine which led to an accidental underdose and needle issue. According to reporter, all syringes and needles were discarded.  The office manager stated that they have another sealed box (10 doses) in the refrigerator and the physician of the practice was concerned about it since it was the same lot that the 8 doses affected and does not want to administer them to her patient.  The reporter reported, the used luer lock needle, the boxes were not damaged, and she was not sure about what needle size was used since she was not the preparer. According to the reporter the doctor was well trained, and she was the one who informed her about the faulty syringes, which led to syringe issue. Credit for 12 doses was pending since reporter had no information regarding wholesaler.  The case was linked with case US2024050698, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2024050698:another patient