Sex: U
Vaccine: PPV
Symptoms: Syringe issue, Underdose
Clinical narrative: no adverse event; Syringe leak; t he pati ent r eceiv ed a smaller than r ecornmended dose of PNEUMOVAX 23; Call er stated ther e is a possibility the leaking was due to user error; Pharmacist reporting an adv er se event and product quality complaint associated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23). Caller stated a patient was administered a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), but after the administration was complete the HCP noticed there was product leaking from where the needle attaches to the syringe. Caller stated due to the leaking the patient received a smaller than recommended dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23). Caller stated there is a possibility the leaking was due to user error as there was no noticeable damage or issues with the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) syringe, but it cannot be confirmed as the HCP did not check the tightness of the needle after administration. Caller stated this product is not available for retrieval nor are pictures able to be taken as the product has already been disposed of. No additional information provided. No additional AE or PQC reported. 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, refer 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, a l so 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 If a needle was attached, was the needle able to be attached securely to the syringe? YES 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? NO o From the tip of the Syringe? NO o Between the syringe hub/ Luer lock and syringe needle? YES 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 After removing the syringe from the tray? NO While trying to attach the needle to the syringe? NO While pulling back on the plunger rod? NO While the plunger rod was being pushed forward? NO Did the plunger rod/ stopper come completely or partially out of the syringe barrel while pulling back on the plunger rod? NO While giving the injection? No After the injection was given. YES  Is there anything that is visible that could explain why the leaking occurred? (e. g. cracked barrel, malformed stopper etc.?) NO DAMAGE TO THE SYR INGE. THE CALLER TH INKS IT MIGHT HAVE OCCURED DUE TO USER ERROR AND THE EMPLOYEE POSSIBILY DID NOT PROPERLY ENSURE THE NEEDLE \VAS TIGHTLY SECURED TO THE SYRINGE. CALLER STATED THE HCP DID NOT CHECK THE TIGHTNESS OF THE NEEDLE AFTER ADMINISTRATION TO CHECK IF THAT IS WHY THE LEAKING OCCURED  Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES *If photos are available, ask the customer to send them  Retrieval Information: Expedited Return Obtain product (& tray if possible) NOTE: Vaccine Prefill ed Syringes may be returned even if biohazardous. Sample Tracking Number: User's Experience: Repeat User Insertion Difficulty: Not Applicable Insertion Difficulty Details: Not Applicable Doubt About Presence: Not Applicable Doubt Details: Not Applicable Migration: Not Applicable Migration Details: Not Applicable Removal Problem: Not Applicable Removal Problem Details: Not Applicable 18-JUL-2022 20:30 PM: Attachment added to Service Cloud. 19-JUL-2022; Second person reviewed