Sex: U
Vaccine: PPV
Symptoms: Exposure via skin contact, Incorrect dose administered, Injection site extravasation, No adverse event
Clinical narrative: Pharmacist stated she gave the patient a second dose (same lot/exp) due to partial dose being administered; during an injection of PNEUMOVAX 23 yesterday some of the medication leaked out and was running down the patient's arm; Leaking During Use / attached a needle securely to the end and once giving the injection/pushing the plunger forward, liquid; during an injection of PNEUMOVAX 23 yesterday some of the medication leaked out and was running down the patient's arm; Caller was initially pharmacy technician (listed as healthcare prof-other, since pharmacy technician is not an option) who reported that during an injection of PNEUMOVAX 23 yesterday some of the medication leaked out and was running down the patient' s arm. Caller then put the pharmacist on the line who actually gave the injection and stated that she used the prefilled syringe that appeared to not be damaged and attached a needle securely to the end and once giving the injection/ pushing the plunger forward, liquid appeared to leak from or near the end. The pharmacist stated she disposed of the syringe in the sharps container and therefore is not able to provide pictures or return to Merck for investigation. Pharmacist stated she gave the patient a second dose (same lot/exp) due to partial dose being administered initially and is inquiring about credit. No further information provided. No other adverse events or product quality complaints 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, 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? NO From the tip of the Syringe? MAYBE Between the syringe hub/Luer lock and syringe needle? YES, POTENTIALLY, THE SYRINGE WAS SECURELY ATTACHED AND THE LIQUID WAS COMING OUT AS THE PLUNGER WAS BEING PUSHED Base of syringe where the plunger rod/stopper is located? NO  Under what situation was this defect noticed: (select one) While the syringe was still in the tray? NO 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? YES, WHILE GIVING INJECTION 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? YES 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.?) COULD NOT SEE CRACK OR ANY OTHER DEFECT AT TIME THAT WOULD INDICATE WHY THIS HAPPENED, SYRINGE WAS DISPOSED.  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 Prefilled 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 03-JUN-2022 15:30 PM: Attachment added to Service Cloud.  Complaint Description Summary  Caller is reporting some of the medication leaked out and was running down the patient's arm.