Sex: U
Vaccine: HIBV
Symptoms: Product complaint, Product leakage, Syringe issue, Underdose, Wrong technique in product usage process
Clinical narrative: leakage 50 percent of the vaccines leak/underdose; reeporter states he uses 25 G needle (luer lok needle) and sometimes he has to use his own syringe to administer the vaccine to the patients; Leakage: 50 of the vaccines leak, either from the tip of the needle, in between the needle and the luer/luer lok issues either breaks or detaches form syringe/Plunger fell out completely; Product Complaint; This non-serious case was reported by a physician via call center representative and described the occurrence of accidental underdose in an unspecified number of patients who received Hib (Hiberix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental underdose (Verbatim: leakage 50 percent of the vaccines leak/underdose), wrong technique in drug usage process (Verbatim: reeporter states he uses 25 G needle (luer lok needle) and sometimes he has to use his own syringe to administer the vaccine to the patients), syringe connection issue (Verbatim: Leakage: 50 of the vaccines leak, either from the tip of the needle, in between the needle and the luer/luer lok issues either breaks or detaches form syringe/Plunger fell out completely) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental underdose, wrong technique in drug usage process, syringe connection issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the syringe connection issue to be related to Hiberix.     It was unknown if the company considered the syringe connection issue to be related to Hiberix.   Additional Information: GSK receipt date: 07-JUN-2024 The reporter reported that he had been having issues too frequently with new Hiberix vaccine design. The reporter stated that the issues below happened always after pulling the medication into the syringe.  The quantity of doses affected were unknown. The reporter stated that he found the following issues: 1. Leakage: 50 percent of the vaccines leak, either from the tip of the needle, in between the needle and the luer lok device. 2. Plunger fell out completely: This issue had happened about 3 times. 3. Luer lok issues: Either broke or detached form syringe, also leaked. The reporter was rude, aggressive and used vulgar language (inappropriate). The reporter was not cooperating with agent to get the proper report the lot number was not provided it was (unknown), quantity affected not provided (unknown), all details about the issues not provided by the reporter. The reporter wanted to provide feedback regarding syringe being flawed. The reporter stated he should inform FDA and government about the issue to put vaccine out of the market until the issue was resolved. The reporter mentioned he was not buying GlaxoSmithKline vaccines and he was switching to another manufacturer. The reporter stated he used 25 G needle (luer lok needle) and sometimes he had to use his own syringe to administer the vaccine to the patients, which led to wrong technique in drug usage process. Apparently sometimes the vaccine leaked during the administration (partial dose), which led to accidental underdose. No information provided regarding patients involved. The reporter did not consent to follow-up.