Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injury associated with device, Product quality issue, Syringe issue
Clinical narrative: This case was reported by a healthcare professional via a vaccine sale manager and a consumer and described the occurrence of needle stick injury in a child subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of PEDIARIX (unknown route and batch number, left thigh). During vaccination with PEDIARIX, the subject experienced needle stick injury. The plunger fell off the syringe and the plastic ring around the needle was not functioning. The manager was unsure if the clinic would ask for replacement or credit to wholesaler account. The customer has retained the syringe in a biohazard container. At the time of reporting, the outcome of the events was unspecified. This case was associated to a product complaint. Follow-up information received on 14 April 2014: Batch number has been added. While the subject received his first injection, the syringe malfunctioned. The white plastic flared end by the plunger came detached causing the syringe to slip in my hand, then causing the needle to bend, and come out of subject's leg, causing a small, very superficial scratch to the leg. This scratch did not bleed. It was not possible to administer the majority of the vaccination and a new vaccination to administer had to prepare. Conclusion of the QA statement as follow : According to the current established process, non-recurrent "faulty backstop" defects do not require a manufacturing investigation. Based on the elements reported by the complainant and the absence of sample to confirm a technical problem, GlaxoSmithKline Biologicals considers this complaint as unsubstantiated. A backstop is designed to improve syringe handling and injection administration. A backstop on a syringe functions as a finger flange extender to offer better syringe handling during drug administration. They prevent accidental withdraw o the plunger during retraction and provide better guidance of the plunger rod. The middle finger and index finger must be kept at rest and secure on the backstop during the injection while the thumb presses the plunger to force the vaccine through the needle. Follow-up information received on 27 May 2014: This case was also reported by a medical assistant. Concurrent vaccination included HIB (non-gsk manufacturer;intramuscular;unknown injection site and batch number), pneumococcal vaccines (non-gsk manufacturer;intramuscular;unknown injection site and batch number) and rotavirus vaccine (non-gsk manufacturer;oral; unknown dose form and batch number), all given on an unspecified date. On an unspecified date, the subject received 2nd dose of PEDIARIX (intramuscular, right thigh). The white plastic flaved grip near the plunger came detached causing syringe to slip in hand and needle bend in subject leg. The subject sustained a scratch to his leg and required an additional injection to administer his vaccine dose (a new one was drawn up). At the time of reporting, the events were resolved with sequelae. According to investigation results received from the Quality Assurance Department on 9 June 2014, GlaxoSmithKline Biologicals considers this complaint as unsubstantiated.