Sex: U
Vaccine: UNK
Symptoms: Device issue, Intercepted medication error, No adverse event, Syringe issue
Clinical narrative: SPIKEVAX syringes breaking when pharmacists are unscrewing the cap; No patient harm as we obviously did not administer these; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (SPIKEVAX syringes breaking when pharmacists are unscrewing the cap), INTERCEPTED MEDICATION ERROR (No patient harm as we obviously did not administer these) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031280) for COVID-19 vaccination.    Co-suspect product included Pre-filled Syringe injection (batch no. 3031280) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced SYRINGE ISSUE (SPIKEVAX syringes breaking when pharmacists are unscrewing the cap), INTERCEPTED MEDICATION ERROR (No patient harm as we obviously did not administer these) and NO ADVERSE EVENT (No adverse event). At the time of the report, SYRINGE ISSUE (SPIKEVAX syringes breaking when pharmacists are unscrewing the cap), INTERCEPTED MEDICATION ERROR (No patient harm as we obviously did not administer these) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for SYRINGE ISSUE (SPIKEVAX syringes breaking when pharmacists are unscrewing the cap) and INTERCEPTED MEDICATION ERROR (No patient harm as we obviously did not administer these).    Quality complaint number QE-030644. No concomitant and treatment medications were reported.   QUALITY-SAFETY EVALUATION OF PTC: The RC-2023-0795 investigation was conducted by the Regulatory Agency for the detachment of the plunger rod from the PFS lot 3031280. This is the 1st complaint related to a detached plunger received in the last 12 months for this batch, indicating the event is not recurrent and is considered as an isolated point event. The investigation was focused on review of the batch documentation and the production logbook. All packaging processes were found satisfactory, and no events linked to settings or incidents that could lead to the claimed defect were reported on the line logbook. The RC of the defect was not found to be attributable to the packaging process of the Regulatory Agency. Machinery was excluded as possible RC since a poor insertion of the plunger rod due to a problem in the applicator clamp or a bad adjustment of assembly machine could lead in the first case to all the units with a faulty insertion, in the second case to a defect appeared recurrently. It was concluded to be very unlikely that the defect occurred in Regulatory Agency, as there was no sufficient force exerting upward pressure to produce the claimed defect during the packaging process. Despite the defect classification as major according to Regulatory Agency SOP 1014QO it was concluded that it doesn't represent a risk to a patient as the product cannot be used in its defective state. No CAPA was deemed necessary as no root cause related to the packaging process was identified. The investigation closed with no further action required. The RC-2023-0795 investigation was conducted by the Regulatory Agency for the detachment of the plunger rod from the PFS lot 3031280. This is the 1st complaint related to a detached plunger received in the last 12 months for this batch, indicating the event is not recurrent and is considered as an isolated point event. The investigation was focused on review of the batch documentation and the production logbook. All packaging processes were found satisfactory, and no events linked to settings or incidents that could lead to the claimed defect were reported on the line logbook. The RC of the defect was not found to be attributable to the packaging process of the Regulatory Agency. Machinery was excluded as possible RC since a poor insertion of the plunger rod due to a problem in the applicator clamp or a bad adjustment of assembly machine could lead in the first case to all the units with a faulty insertion, in the second case to a defect appeared recurrently. It was concluded to be very unlikely that the defect occurred in Regulatory Agency, as there was no sufficient force exerting upward pressure to produce the claimed defect during the packaging process. Despite the defect classification as major according to Regulatory Agency SOP 1014QO it was concluded that it doesn't represent a risk to a patient as the product cannot be used in its defective state. No CAPA was deemed necessary as no root cause related to the packaging process was identified. The investigation closed with no further action required.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2023: Live follow up information received by safety on 16-Oct-2023 does not contain any new information On 16-Oct-2023: Follow-up received with no new significant information. On 09-Jan-2024: Significant follow-up received -Closed investigation report received.