Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Device difficult to use, Device issue, Exposure to body fluid, Medical device change, Needle issue
Clinical narrative: No known side effects noted after vaccination with defective product; the vial has "dulled" the needle; difficult to pierce the vial stopper; difficult to pierce the vial stopper; difficult to pierce the vial stopper; Information was received from a nurse concerning a 1-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. The patient's drug reactions or allergies were unknown.  On 17-JAN-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (1 dose, quantity: 1, lot number X021280 has been verified to be a valid lot number and expiration date was 20-AUG-2025, frequency and anatomical location were not reported) intramuscularly for prophylaxis.  The reporter reported difficulty with administering the varicella virus vaccine live (oka/merck) (VARIVAX) after it had been drawn up and she felt as though the rubber stopper from the vial has "dulled" the needle, reported difficulty with puncturing the vial of varicella virus vaccine live (oka/merck) (VARIVAX) (needle issue, poor quality device used). The reporter attempted to administer the vaccine and stated the needle "bounced" off of the patient's skin; the needle was then swapped out and varicella virus vaccine live (oka/merck) (VARIVAX) was administered. No photos were able to be provided as varicella virus vaccine live (oka/merck) (VARIVAX) was discarded of after vaccination. The varicella virus vaccine live (oka/merck) (VARIVAX) also cannot be retrieved for this same reason. One cause for difficulty piercing the stopper was when the flip cap fails to remove the inner metal area of the metal crimp, so the rubber stopper was not exposed (product use complaint, product closure issue). The stopper was penetrability irregularity and was primary packaging. This would prevent the needled from being inserted. The center of the rubber stopper was visible after removing the flip cap. It felt like the needle was not sturdy so made the reporter felt it was too difficult or too easy to pierce. while inserting the needle into the stopper and the stopper was more difficult to get through. Syringe needle was used to pierce the vial. The size syringe, gauge and length of needle was 5/8 inch 25 gauge. The intravenous (IV) spike adaptor or syringe inserted at 90-degree angle in the center of the stopper. The product administered or exposed to patient's bodily fluids (i.e. biohazardous). The reporter tried to administer to a patient and was unable to insert needle into skin; The reporter then switched the needle and administered the product. This was a third-party syringe and it was not supplied by company. The reporter also reported they had used these same needles for other vaccines and had not had any issues, therefore the reporter did not believe it was a needle issue and rather an issue with the varicella virus vaccine live (oka/merck) (VARIVAX) rubber stopper. No known side effects noted after vaccination with defective varicella virus vaccine live (oka/merck) (VARIVAX). No additional adverse event (AE) (no adverse event).