Sex: U
Vaccine: COVID19
Symptoms: Device issue, Device leakage, No adverse event
Clinical narrative: when they looked closely at the syringe to apply the needle, the plunger pulled completely out of the syringe and there was no liquid in the little vial; when they looked closely at the syringe to apply the needle, the plunger pulled completely out of the syringe and there was no liquid in the little vial; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE ISSUE (when they looked closely at the syringe to apply the needle, the plunger pulled completely out of the syringe and there was no liquid in the little vial), DEVICE LEAKAGE (when they looked closely at the syringe to apply the needle, the plunger pulled completely out of the syringe and there was no liquid in the little vial) 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. 3032680) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection (batch no. 3032680) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (when they looked closely at the syringe to apply the needle, the plunger pulled completely out of the syringe and there was no liquid in the little vial), DEVICE LEAKAGE (when they looked closely at the syringe to apply the needle, the plunger pulled completely out of the syringe and there was no liquid in the little vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE ISSUE (when they looked closely at the syringe to apply the needle, the plunger pulled completely out of the syringe and there was no liquid in the little vial), DEVICE LEAKAGE (when they looked closely at the syringe to apply the needle, the plunger pulled completely out of the syringe and there was no liquid in the little vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. It was reported that the HCP did not know if product was in blister pack. HCP further clarified that one of the nurses was preparing the vaccine and opened a box of Spikevax PFS the box itself looked fine. Upon breaking the seal of the package nothing appeared wrong but when they looked closely at the syringe to apply the needle, the plunger pulled completely out of the syringe and there was no liquid in the little vial. HCP confirmed that they did not administer the product. The packaging was completely sealed. They used another one. The product was not available for return.  The Pharma Industrial Services site performed an investigation in response to the product complaint QE-032682, for the defect reported as "empty PFS" for one PFS with CMO batch number 3032680. A 6M analysis have been performed, focused on filling and inspection steps, as well as the primary packaging material incoming inspection. Syringes and stoppers were tested at incoming Material Laboratory and no defects or anomalies were detected during incoming analysis. No empty syringes have been detected during the filling and visual inspection step. All Production and In Process Control staff from filling and inspection steps were correctly qualified. All reference samples have been reviewed and all of them were filled. In conclusion, after batch record documentation review, it has not been detected any incidence which could led to empty syringe defect. In addition, claimed defect was not detected observed during the packaging controls performed at Pharma Industrial Servicessite. The defect can not be confirmed as no sample nor picture is received. Therefore, after the investigation carried out, the complaint is classified as Non Attributable. As a result, no CAPA was deemed necessary. The investigation is closed with no further action required, as no root cause was identified.   QUALITY-SAFETY EVALUATION OF PTC: Performed an investigation in response to the product complaint QE-032805, for the defect reported as detached plunger for one PFS with CMO batch number 3032680. The investigation was focused on review of the batch documentation and the production logbook. All packaging processes were found to be satisfactory, and no events related to Combi Machine (assembly machine) s or incidents that could have resulted in the claimed defect were reported on the line logbook. All elegance test carried out overall packaging of the claimed batch were satisfactory. Additionally, the event could be considered as isolated since one defect unit was found for the batch 3032680 (1 units out of 241.170 is equals to 0.000415%). It was concluded to be very unlikely that the defect occurred in facility, since the assemble machine has a specific control able to detect a syringe in which the plunger rod is not placed and there is no sufficient force exerting sufficient pressure to pull out the plunger rod with the stopper out of the syringe during the packaging process. The investigation is closed with no further action required.  The Spikevax syringe device was malfunctioned, and the type was CIRM. The Device problem code for Spikevax syringe include FDA code 1250, IMDRF code A050401 which include Fluid Leak. The Device problem code for Spikevax syringe include FDA code 2907, IMDRF code A0501 which include Detachment of Device or device Component. The Evaluation / Investigation Code for Spikevax syringe included FDA CODE 3331, IMDRF code B14, Method/type was Analysis of Production Records and FDA CODE 3221, IMDRF code C20, Result/Findings was No Findings Available. The conclusion was Cause Not Established, FDA Code 4315 and IMDRF Code D15.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2024: Live Follow-up received with PQC report. References added. On 19-Jan-2024: Non-significant Follow-up received, and Product Quality complaint (PQC) report was added. On 26-Mar-2024: Significant Follow-up received with Closed PQC investigation report. Updated QC date, QC comment and narrative accordingly.