Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Device issue, No adverse event
Clinical narrative: HCP tried to administer a Moderna 6 mth - 11 year syringe to a patient, but once the needle went into the skin, the plunger wouldn't plunge; No adverse effect; HCP tried to administer a Moderna 6 mth - 11 year syringe to a patient, but once the needle went into the skin, the plunger wouldn't plunge; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE ISSUE (HCP tried to administer a Moderna 6 mth - 11 year syringe to a patient, but once the needle went into the skin, the plunger wouldn't plunge), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP tried to administer a Moderna 6 mth - 11 year syringe to a patient, but once the needle went into the skin, the plunger wouldn't plunge) and NO ADVERSE EVENT (No adverse effect) in a 6-year-old female patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (batch no. 3044079) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 3044079) for COVID-19 prophylaxis.    Concomitant products included Influenza vaccine from 15-Oct-2024 to an unknown date for an unknown indication.   On 15-Oct-2024, the patient received fourth dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (unknown route) .25 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 15-Oct-2024,  after starting mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS), the patient experienced DEVICE ISSUE (HCP tried to administer a Moderna 6 mth - 11 year syringe to a patient, but once the needle went into the skin, the plunger wouldn't plunge). On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP tried to administer a Moderna 6 mth - 11 year syringe to a patient, but once the needle went into the skin, the plunger wouldn't plunge) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (HCP tried to administer a Moderna 6 mth - 11 year syringe to a patient, but once the needle went into the skin, the plunger wouldn't plunge), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP tried to administer a Moderna 6 mth - 11 year syringe to a patient, but once the needle went into the skin, the plunger wouldn't plunge) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.        For mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   HCP removed syringe and attempted to administer dose a second time and the same thing happened. HCP was afraid to use the rest of the carton, as this was the first syringe from that carton to be used. HCP noted that the syringe rod will go in and out when not in the patient's arm. The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem. The evaluation/investigation code for Spikevax syringe include FDA code 13, IMDRF code C1303 which include Device Difficult to Operate. Treatment medication was not reported.  Investigation Summary & Conclusion with Root Cause Details was reported as the complaint concerned a syringe with a plunger rod that was difficult to push or pull for dose administration. A deeper investigation was requested to the Contract Manufacturing Organization (CMO) on October 24, 2024. Although the defective sample was available for collection, the CMO confirmed it could not be sent to their facilities as it had been used on a patient. The CMO conducted a thorough investigation, reviewing the batch record documentation, in-process controls, control system challenges, related investigations, packaging materials, and other associated complaints. They concluded that all aspects were compliant, with no observations warranting further investigation into the batch-related documentation  Additionally, the CMO examined their processes, specifically the insertion of the plunger rod. In this process, plunger rods are inserted using a rotor that lowers and inserts them into the syringe to a validated measurement. A potential root cause was identified: improper insertion of the plunger rod could occur if the rotor cylinder's height, containing the applicator clamps in the assembly machine, is not correctly adjusted, or if there is an issue with one of the clamps. However, since all units would show the defect, and the elegance test would have detected such an issue, machinery was ruled out as the root cause. If the plunger rod insertion fails, the machine would reject the syringe.  After the investigation, no root cause was attributed to Rovi's processes for the reported defect. It's important to consider that external factors, such as the thawing process, needle type, and syringe handling, might influence the force required to apply the plunger rod for dose administration. An evaluation of the complaint trend analysis for lot 3044079, specific to this failure mode, confirmed that the complaint did not indicate a trend for this defect.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2024: Live non-significant follow-up received; Reference number added. On 06-Dec-2024: Significant follow-up received. Updated QC comment and narrative.