Sex: U
Vaccine: COVID19
Symptoms: Device issue, Device leakage, No adverse event
Clinical narrative: The adult dosing syringes have proved a little difficult at times to un-twist the cap; We had a nurse who felt some of the caps were hard to remove, and then the vaccine happened to leak out while she was injecting even though the syringe was on tight; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE ISSUE (The adult dosing syringes have proved a little difficult at times to un-twist the cap), DEVICE LEAKAGE (We had a nurse who felt some of the caps were hard to remove, and then the vaccine happened to leak out while she was injecting even though the syringe was on tight) 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. 3030339) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 3030339) 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) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (The adult dosing syringes have proved a little difficult at times to un-twist the cap), DEVICE LEAKAGE (We had a nurse who felt some of the caps were hard to remove, and then the vaccine happened to leak out while she was injecting even though the syringe was on tight) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE ISSUE (The adult dosing syringes have proved a little difficult at times to un-twist the cap), DEVICE LEAKAGE (We had a nurse who felt some of the caps were hard to remove, and then the vaccine happened to leak out while she was injecting even though the syringe was on tight) 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.   Concomitant and Treatment information was not provided by the reporter.  Reporter reported an issue with Spikevax syringe for which adult dosing syringes have proved a little difficult at times to un-twist the cap and some of the caps were hard to remove, and then the vaccine happened to leak out while she was injecting even though the syringe was on tight. It has only happened twice so far, and she have both of those vials in her possession. Two syringes of the pre-filled syringe were affected by this event. Both syringes were being administered to patients when the leaking was noted. The nurse stated that the caps are not easy to remove but did not appear any different from the ones that leaked versus the ones that did not leak. Nurse stated syringe was noted to be leaking through the threads. Nurse do have both syringes in possession and will be sending them back. Syringes were only uncapped when ready to administer (after 15 minutes out of fridge). Malfunction was reported as yes. Malfunction type was CIRM. The Device problem code for Spikevax syringe include code 1250 and 2921, IMDRF code A050401 and A051104 which include Fluid Leak and Difficult to Open or Close. Evaluation and Investigation codes included code 4114, IMDRF code B17 Method / type Device Not Returned. code 4248, IMDRF code C23, result/ findings as Usage Problem Identified. code 114, IMDRF code C13, result/ findings as Operational Problem Identified.  QC Comment: In a follow up conversation with the Healthcare provider (HCP), it was reported that during administration leaking occurred at the Luer Lock connection. The HCP confirmed that there was no damage to the packaging, carton box or syringe packaging itself. The syringe was inspected before administration and there were no visible signs of leaking. If the HCP believed that the connection between the needle and the syringe was tight, but if it was misaligned, creating a weak spot between the plastic hub and the needle, when pressure is applied during the administration process, product can leak out at the Luer Lock connection. This is the location that the HCP confirmed product was leaking out at. There have been two complaints for batch (3030339) in the last twelve months (24Oct2022-24Oct2023), one for PFS cap hard to remove and the other for "leaking". A trend analysis was performed for the last 12 months for this defect and the batch in question (3030339) did not exceed the action limit (3 standard deviations from the mean). Please refer to Minor Trending Memo in the attachments section. No further investigation is recommended at this time. The Risk Level was downgraded to Minor after the Healthcare provider confirmed that leaking was noted at the Luer Lock location, following needle attachment and administration. Moderna does not provide the needles for administration. Minor- A complaint that requires attention, but which alone, is unlikely to impact product safety, identity, strength, purity, and/or quality. The Complaint does not represent a serious, systemic, or recurrent noncompliance to a regulatory standard or quality system. The actual device involved in the adverse event was not returned for testing despite requests by manufacturer.   This case was linked to US-MODERNATX, INC.-MOD-2023-753442 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2023: Significant follow-up received included, closed PQC report. Added QC-comment and QC result date. Updated I-narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-753442: