Sex: U
Vaccine: PPV
Symptoms: Syringe issue
Clinical narrative: No aditional AE; The medicine leaked out / the medication leaked out from the syringe; Potential nurse exposure during administration to the patient; Complaint Description Detail  Customer reported a malfunctioned pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe. She reported during administration on the patient's leg, the medication leaked out from the syringe. This AE is created for the patient. AE created in case 02264905 for potential nurse exposure during administration to the patient as a precaution. No PQC reported. No further information was provided. mailer sent.  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, 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 - 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?  - From where did the leaking occur? (select one) - From the tip of the Syringe Needle? NA - From the tip of the Syringe? NA - Between the syringe hub/Luer lock and syringe needle? YES - Base of syringe where the plunger rod/stopper is located? NA - Under what situation was this defect noticed: (select one) - While the syringe was still in the tray? NA - If yes, is there still product (liquid or residue) in the blister tray? YES/NO/NA/UNSPECIFIED - 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? NA - Did the plunger rod/stopper come completely or partially out of the syringe barrel while pulling back on the plunger rod?YES/NO/NA/UNSPECIFIED -While giving the injection? YES -After the injection was given? NA  Is there anything that is visible that could explain why the leaking occurred? (e.g. cracked barrel, malformed stopper. .. etc.?) NO Was the product administered or exposed to patient's bodily fluids(i.e. biohazardous)? YES IT LEAKED ON THE PATIENTS LEG  If photos are available, ask the customer to send them to email: CALLER SAID SHE WOULD TAKE THE PICTURES AND SEND THEM  Retrieval Information: Expedited Return Obtain product (& tray if possible) NOTE: Vaccine Prefilled Syringes may be returned even if biohazardous. BIO MAILER SENT 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  10-OCT-2022 17:30 PM :Attachment added to System. 10-OCT-2022 17:30 PM :Attachment added to System. 10-OCT-2022 17:30 PM :Attachment added to System. 10-OCT-2022 17:30 PM :Email received in the System Contact Center Mailbox on 10-OCT-2022 at 3:09pm with a picture related to this case. Picture embedded within the email so picture was saved within a PDF file and attached separately. See attachment. 10-OCT-2022 17:30 PM :Attachment added to System. 10-OCT-2022 17:30 PM :Attachment added to System. 10-OCT-2022 17:30 PM :Case re-opened to fix the details. 10-OCT-2022: Photo received & attached 10-OCT-2022; Second person reviewed 11-OCT-2022; Second person reviewed