Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: No additional AE; something is wrong at the base of the syringe where it meets the hub which looks offset a little bit. Fluid came out bottom of hub (PFS); he is unsure how much was received by patient.; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.  On 21-JUL-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe, at a dose of 0.5 milliliter, lot #U034712, expiration date: 30-JUL-2023 (strength, route of administration and anatomical location were not provided) administered for prophylaxis. The reporter stated that while giving the injection, something was wrong at the base of the syringe where it met the hub and that the hub looked offset a little bit (syringe issue); fluid came out bottom of hub as he began to push, and he was unsure how much was received by patient (Incorrect dose administered).  The reporter stated he had been a nurse for 8 years and this was the first time he had seen this issue. No additional adverse event was reported (no adverse event).  Complaint Description Detail: Nurse reporting an AE. Caller stated that fluid came out bottom of hub (PFS) as he began to push and he is unsure how much was received by patient. Caller stated something is wrong at the base of the syringe where it meets the hub and that the hub looks offset a little bit. Per caller, this is not an issue with the connection between needle and hub. Caller stated he has been a nurse for 8 years and this is the first time he has seen this issue. No additional AE/PQC.  QUESTIONS SECTION:  IF REPORTED:  PQC Prefilled Syringe: PQC Prefilled Syringe: Syringe Needle Defects Dull Bent Damaged Missing Syringe Needle Hub Defects Broken Wrong Color Syringe Needle Sheath Cover Defects Damaged Missing, Dislodged  (High Risk)  QUESTIONS SECTION:  - What are the lot number(s) on the product/carton? U034712, 30-JUL-2023 NOTE: This is needed to identify the needle supplied with the kit. - Please identify which part of the syringe needle is affected NA. NO NEEDLE ISSUE. HUB ISSUE. - Please provide a detailed description of the complaint defect. HUB IS OFFSET TO THE RIGHT. IF I TRY TO WIGGLE IT, IT DOES WIGGLE A LITTLE BIT. FIRST TIME SEEN THIS IN 8 YEARS - Under what situation was this defect noticed: (select one) f the syringe needle is not integrated into the syringe: - Prior to removing the needle sheath? NA - After remove the needle sheath? NA - Prior to attaching the needle to the body of the syringe? NA - While attaching the needle to the syringe? NA - While giving the injection? YES PRODUCT CAME OUT AT THE HUB WHERE THE HUB MEETS THE HAMBER THAT HOLDS THE PRODUCT WHEN CALLER BEGAN PUSHING THE PRODUCT. - After the injection was given? NA - If Syringe needle is integrated into the body of the syringe: - Prior to removing the needle sheath? NA - After remove the needle sheath? NA - While giving the injection? NA - After the injection was given? NA - If the complaint is for a dull needle: - Did you/the patient allow at least one minute for the disinfectant (e.g. alcohol) to dry on your/the patient' s skin before inserting the needle? NA - Did you/the patient use an alcohol swab on the syringe needle? NA NOTE: An alcohol swab should not be used on the syringe needle as it removes the silicone - Did you/the patient use a "slightly" different injection site than the last injection? NA - Have you/the patient injected yourself/herself at this injection site before? NA - Did you/the patient insert the needle into the body at an angle of 45 to 90 ? NA - Did you/the patient draw blood into the syringe and need to reposition the needle without removing from the skin? NA - How many times did you/the patient try to inject the syringe? inject the syringe once) NA  - Was the product dropped? NO  - Was the syringe tray intact and undamaged on receipt? YES - If no, describe damage. - If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. NA  - If no, describe damage - Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NA - If yes, describe - Was the product administered or exposed to patient's bodily fluids(i. e. biohazardous)? YES - If complaint sample is not/cannot be returned, please provide reason:  - *If photos are available, ask the customer to send them Retrieval Information:  Obtain product (& tray if possible). Ensure enough absorbent material is provided to prevent breakage.  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  21-JUL-2022 16:30 PM: Attachment added. 21-JUL-2022 16:30 PM: Attachment added. 21-JUL-2022 16:30 PM: Case closed in error, re opened to place in submitted state while waiting for product retrieval. Task added. 21-JUL-2022 16:30 PM: Attachment added. 21-JUL-2022 16:30 PM: Waiting for Retrieval Site from Quality--See attachments 22-JUL-2022: Second person reviewed. 22-JUL-2022 12:30: Attachment added. 25-JUL-2022: Received & Attached failure-Missing info added below 22-JUL-2022T12: 08:00-04:00  Complaint Sample description: <not set>  Complaint Description Summary: caller is reporting that the hub looks offset and wiggles a little bit, and also stated that fluid came out bottom of hub (PFS) as he began to push.