Sex: U
Vaccine: COVID19
Symptoms: Device breakage, Device leakage, No adverse event
Clinical narrative: When he pulled the gray rubber stopper, the plunger came out; Syringe was leaking from rubber tip cap; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE BREAKAGE (When he pulled the gray rubber stopper, the plunger came out), DEVICE LEAKAGE (Syringe was leaking from rubber tip cap) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030366) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection (batch no. 3030366) for COVID-19 prophylaxis.    No Medical History information was reported.   On 30-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE BREAKAGE (When he pulled the gray rubber stopper, the plunger came out), DEVICE LEAKAGE (Syringe was leaking from rubber tip cap) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE BREAKAGE (When he pulled the gray rubber stopper, the plunger came out), DEVICE LEAKAGE (Syringe was leaking from rubber tip cap) 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 medications were reported.  When he pulled the gray rubber stopper, the plunger came out, He does not think the liquid spilled over the vaccinator's skin. The prefilled syringe was broken or cracked.  The Device problem code for Spikevax syringe include FDA code 1069 and 1250, IMDRF code A0401and A050401 which include break and fluid leak.  The Spikevax syringe device was malfunctioned, and the type was Not CIRM.  No treatment medications were provided.   QUALITY-SAFETY EVALUATION OF PTC: Rovi Alcalá de Henares(AH) performed a complete investigation for the Defect/Defect Detail reported of Syring/Plunger Rod/Fell out of Syringe barrel for one PFS from CMO batch number 3030366 (See the report attached "RC-2023-0858" for the investigation performed and "Rovi SCAR report RC-2023-0795 - QE-030644 (Detached plunger case)_Reviewed_Rovi" report, used as reference case, for additional information provided). Rovi AH classified this defect as Minor according to their Risk Priority Number. A 6M analysis was performed by Rovi for investigating the Root Cause of this event. Regarding recurrence, this is the second complaint related to "plunger rod with the stopper fell out"received at Rovi AH during the last 12 months for the same product and customer. It is the first received for lot 3030366 therefore, this event is not considered recurrent. Rovi AH excluded Machinery as possible root cause since a poor insertion of the plunger rod due to a problem in the applicator clamp. A bad adjustment of assembly machine could lead to all the units with a faulty insertion with the defect appearing recurrently. This event is considered isolated since only one defect unit was found for the batch 3030366 (1 unit out of 23,343 PFS shipped for the batch is 0.0042839%).Therefore, it is possible to conclude that this could be considered as a point event. After the investigation performed by Rovi AH, no root cause for the claimed defect could be assigned to Rovi AH, therefore this complaint was classified as non-attributable at Rovi AH and no CAPA was proposed.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2023: Live follow up received contains PQC report added and reference numbers added. On 30-Oct-2023: Non-Significant Information Received. On 21-Dec-2023: Significant follow-up received contains start date of suspect added, QC comment added, start date of events added, narrative updated.