Sex: U
Vaccine: COVID19
Symptoms: Device adhesion issue, No adverse event, Product blister packaging issue, Wrong technique in device usage process
Clinical narrative: packaging is terrible (blister packs), it is very hard to get into the packaging; Also the rubber stopper that you have to twist off to put a needle on it, it sticks way too much, it is ridiculous to pull it off and sometimes; Therefore, we can conclude that the claimed defect "rubber tip cap that sticks to the syringe barrel" could be related to the unscrewing technique of the HCP.; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT BLISTER PACKAGING ISSUE (packaging is terrible (blister packs), it is very hard to get into the packaging), DEVICE ADHESION ISSUE (Also the rubber stopper that you have to twist off to put a needle on it, it sticks way too much, it is ridiculous to pull it off and sometimes), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Therefore, we can conclude that the claimed defect "rubber tip cap that sticks to the syringe barrel" could be related to the unscrewing technique of the HCP.) 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. 3031047) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection (batch no. 3031047) 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 PRODUCT BLISTER PACKAGING ISSUE (packaging is terrible (blister packs), it is very hard to get into the packaging), DEVICE ADHESION ISSUE (Also the rubber stopper that you have to twist off to put a needle on it, it sticks way too much, it is ridiculous to pull it off and sometimes), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Therefore, we can conclude that the claimed defect "rubber tip cap that sticks to the syringe barrel" could be related to the unscrewing technique of the HCP.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT BLISTER PACKAGING ISSUE (packaging is terrible (blister packs), it is very hard to get into the packaging), DEVICE ADHESION ISSUE (Also the rubber stopper that you have to twist off to put a needle on it, it sticks way too much, it is ridiculous to pull it off and sometimes), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Therefore, we can conclude that the claimed defect "rubber tip cap that sticks to the syringe barrel" could be related to the unscrewing technique of the HCP.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT BLISTER PACKAGING ISSUE (packaging is terrible (blister packs), it is very hard to get into the packaging), DEVICE ADHESION ISSUE (Also the rubber stopper that you have to twist off to put a needle on it, it sticks way too much, it is ridiculous to pull it off and sometimes) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Therefore, we can conclude that the claimed defect "rubber tip cap that sticks to the syringe barrel" could be related to the unscrewing technique of the HCP.).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT BLISTER PACKAGING ISSUE (packaging is terrible (blister packs), it is very hard to get into the packaging), DEVICE ADHESION ISSUE (Also the rubber stopper that you have to twist off to put a needle on it, it sticks way too much, it is ridiculous to pull it off and sometimes) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Therefore, we can conclude that the claimed defect "rubber tip cap that sticks to the syringe barrel" could be related to the unscrewing technique of the HCP.).    No concomitant medications were reported.  Reporter informed that first of all the packaging was terrible (blister packs), it was very hard to get into the packaging, the perforation between syringe packets it does not tear easily, the foil or plastic film that keeps it inside, it was very hard to peel back. Also, as per the reporter, the rubber stopper that had to twist off to put a needle on it, it sticks way too much, it was ridiculous to pull it off and sometimes, half the time when pulling it off the rubber stopper remains intact, the plastic over the rubber stopper comes off and then they had to pull the rubber stopper after they were playing with it, and whoever designed it did a horrible job according to the reporter and it was different than all other PFS in the market as per the reporter.  According to the reporter, they had already been using the product with a lot of patients (no specific details on demographics for each patient) and for each single syringe, it was the same regardless of lot number (but gave as example lot number 3031047), since they started receiving shipments of the vaccine on 6-Oct-2023 was all the same and that had been a huge complaint among personnel at the facility, it was highly frustrating to use that product as per the reporter.  The Device problem code for Spikevax syringe include FDA code 2922, Agency code A020501 which include Difficult to Open or Remove Packaging Material. FDA code 1670, Agency code A23 which include Use of Device Problem. The malfunction was reported as yes and malfunction type as Agency.  The packaging enclosing the syringe was not easy to open. The wrapping was difficult to tear off. The reporter had to squeeze the packaging around the syringe to help facilitate the plastic wrap to come off. The most irritating issue that the reporter experienced was that the vaccine was incredibly sticky. It caused the rubber tip cap to stick really tightly around the syringe barrel. It took a lot of force to pull it off. Unscrewing the rigid cap came off without pulling the rubber cap tip off. The rubber cap tip stayed lodged in the syringe barrel and sticks to the syringe barrel.  Rationale for no investigation was reported as : After previous investigations performed by Agency (syringe supplier) for difficulties when removing the rigid cap from the PFS, it was concluded that no root cause was found at Agency. However, the RC was most likely related to the end user who did not correctly unscrew the PFS. The tip cap mechanism has an elastic strain when unscrewing, and the end user needs to continue unscrewing, in a linear, slow and steady motion, without applying pulling forces, to overcome this strain and properly open the PFS. Agency provided with an "Instruction manual for TRC opening" (see attached). In the section "Possible malfunctions during unscrewing", it states that in case of unscrewing the TRC in an angular position (not linear), the plug may remain attached to the cone. Therefore, we can conclude that the claimed defect "rubber tip cap that sticks to the syringe barrel" could be related to the unscrewing technique of the HCP. Thus, the case will be closed with no further investigation recommended at this time. Since it is the first case received for this defect detail "Will not separate from barrel", a trending memo could not be perform because there is no value for the mean + 3 StD. But it can be confirmed that it's not a recurrent defect.  It was reported that the biggest problem was the rubber stopper used to seal the syringe. The vaccine comes in contact with the rubber stopper and dries to the rubber stopper making it stick tightly to the walls of the syringe. They had to really pull on the stopper to take it off. The outer twist cap also does not adhere to the rubber stopper so they first pull off the twist cap then they have to pull off the rubber stopper. It was not too big of an issue if only giving one or two doses at a time but when they continually give the vaccine to several patients it was getting extremely annoying. It was also very difficult for anyone who does not have sufficient strength to continually tug on the rubber stoppers.  It was also reported that there was no adverse event. It was just poor manufacturing processes by the company.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2023: Significant follow-up received. Primary reporter details and narrative updated. On 23-Nov-2023: Non-significant information received: reference number and PQC number updated.