Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: no adverse event; Inappropriate schedule of vaccine administered; during administration of GARDASIL 9 to a 12 years old male patient, the syringe dislodged from the needle and most of the vaccine ran down the side of the patient's arm; the product was leaking from a site other than the product dispensing site and the product was leaking from the dispensing point; the syringe dislodged from the needle and most of the vaccine ran down the side of the patient's arm the needle dislodged from the syringe and the needle was still in the patient's arm; This spontaneous report was received from a medical assistance and refers to a 12-year-old male patient. His medical history, concurrent conditions, and concomitant therapies were not reported.  On 02-MAR-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (exact dose, injection site, lot #, expiry date, and route of administration were not provided).  On 05-AUG-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, injection, administered for prophylaxis by the another Health Care Professional, lot# U007665, expiration date 23-MAY-2023 (exact dose, injection site, and route of administration were not provided) (inappropriate schedule of product administration).  During the second administration the syringe dislodged from the needle and most of the vaccine ran down the side of the patient's arm. When the vaccine was actively being administered, the needle dislodged from the syringe and was still in the patient's arm. The product was leaking from a site other than the product dispensing site, as it was from the dispensing point. The patient did not experience any side effects. The product was discarded.   The causality between the events, and the suspect vaccines was not reported.  Complaint Description Detail Agent, transferred a HCP onto the line. HCP reports that during administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) to a 12 years old male patient, the syringe dislodged from the needle and most of the vaccine ran down the side of the patient's arm. HCP reports that when the vaccine was actively being administered, the needle dislodged from the syringe and the needle was still in the patient's arm. HCP reports that the product was leaking from a site other than the product dispensing site and the product was leaking from the dispensing point, therefore high-risk was selected. HCP reports that the vaccine HCP reports the patient received their first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 02-MAR-2021 with a different HCP. HCP reports the patient was being administered his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 05-AUG-2022 when the event occurred. HCP reports that the patient did not experience any side effects. Consent to contact HCP was provided. Customer unable to provide photos and unable to return product as the product was discarded. No additional AEs/no additional PQCs. QUESTION SECTION: High Risk: Leaking Prior to Opening High Risk: Leaking during use from a site other than the product dispensing point Medium Risk: Leaking during use from the product dispensing point NOTE: Most MERCK prefilled syringes require a syringe needle to be attached to the hub or tip of the syringe using a Luer Lock attachment by the healthcare provider; which allows the needle to be twisted onto the tip and then locked in place. NOTE: Confirm that the syringe is not cracked or broken, including a broken or loose Luer Lock adaptor. If there is any sign of breakage, ref er to the appropriate broken/ cracked syringe article. Additionally, if there was difficulty attaching the syringe needle, and the leakage occurred at the syringe tip and syringe needle area of attachment, also refer to the Prefilled Syringe: Broken/Cracked Article. For syringes when the customer must attach a needle: Was the syringe needle attached to the syringe tip before the leaking occurred? YES. o If a needle was attached, was the needle able to be attached securely to the syringe? YES. o If no, describe what issue was encountered while attaching the needle? N/A From where did the leaking occur? (select one) o From the tip of the Syringe Needle? YES. THE CALLER REPORTS THE NEEDLE WAS STILL IN THE PATIENT'S ARM AND PART OF IT LEAKED OUT FROM WHERE THE NEEDLE ATTACHES TO THE SYRINGE AND THE REST OF IT WAS LEAKING FROM THE SYRINGE. THE CALLER REPORTS THAT IT WAS LEAKING DURING ADMINISTRATION WHEN ACTIVELY PUSHING ON THE PLUNGER. o From the tip of the Syringe? YES. THE CALLER REPORTS THE NEEDLE WAS STILL IN THE PATIEN' TS ARM AND PART OF IT LEAKED OUT FROM WHERE THE NEEDLE ATTACHES TO THE SYRINGE AND THE REST OF IT WAS LEAKING FROM THE SYRINGE. THE CALLER REPORTS THAT IT WAS LEAKING DURING ADMINISTRATION WHEN ACTIVELY PUSHING ON THE PLUNGER.  o Between the syringe hub/Luer lock and syringe needle? NO.  o Base of syringe where the plunger rod/stopper is located? NO.  Under what situation was this defect noticed: (select one)  o While the syringe was still in the tray? NO.  o If yes, is there still product (liquid or residue) in the blister tray? NA.  o After removing the syringe from the tray? NO.   o While trying to attach the needle to the syringe? NO. While pulling back on the plunger rod? NO.   o While pulling back on the plunger rod? NO. o While the plunger rod was being pushed forward? YES. THE CALLER REPORTS THE DEFECT WAS NOTICED WHEN THE VACCINE WAS ACTIVELY BEING GIVEN. o Did the plunger rod/stopper come completely or partially out of the syringe barrel  o while pulling back on the plunger rod? NO.  o While giving the injection? YES. THE CALLER REPORTS THE DEFECT WAS NOTICED WHEN THE VACCINE WAS ACTIVELY BEING GIVEN. After the injection was given? NO. Is there anything that is visible that could explain why the leaking occurred? (e.g. cracked barrel, malformed stopper etc. ?) NO. THE CALLER REPORTS THAT NOTHING IS VISIBLE TO EXPLAIN WHY THE LEAKAGE OCCURRED. THE CALLER REPORTS THAT THE VACCINE WAS DISCARDED. Was the product administered or exposed to patient' s bodily fluids(i. e. biohazardous)? NO. Retrieval Information: Expedited Return *If photos are available, ask the customer to send them to manufacturer THE CALLER REPORTS THAT PHOTOS ARE NOT AVAILABLE AS THE PRODUCT WAS DISCARDED. Obtain product (& tray if possible) NOTE: Vaccine Prefi lled Syringes may be returned even if biohazardous. Sample Tracking Number: User's Experience: Repeat User Insertion Difficulty: Insertion Difficulty Details: Doubt About Presence: Doubt Details: Migration: Migration Details: Removal Problem: Removal Problem Details: 15-AUG-2022 19:30 PM: The customer only had the lot number available at the time of the call for the administered dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The customer discarded the product and cannot return the product back or send any photos. No additional AEs/no additional PQCs. 15-AUG-2022 19:30 PM: Attachment added. 16-AUG-2022: Second person review performed 18-AUG-2022: Upon further review, Leaking During Use - From Product Dispensing Point has been removed from both the Reported & Investigated PQC Categories and the device cope updated accordingly. 18-AUG-2022: Second person review performed  18-AUG-2022 14:30 PM: Inbound call 23-MAY-2023 for the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No other information provided.