Sex: U
Vaccine: PPV
Symptoms: Needle issue
Clinical narrative: Tip Cap AskewSterile Injectable;Needle Detached;Syringe Hub Defect; Sterile Injectable;Cannot Attach Needle;; Sterile Injectable;Cannot Attach Needle;Syringe Hub DefectSterile Injectable;N/A;Tip Cap AskewSterile Injectable;Needle Detached;Syringe Hub Defect; No adverse event; Complaint Description Detail Health care provider (HCP) calling to report product quality complain (PQC) associated with 2 lots of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) PFS. Caller reported that HCP users had had difficulty screwing safety needles into syringe hubs and needles do no securely stay in place. On 2 occasions, the needle dislodged from the syringe hub 1) while attempting to attach safety needle cap and 2) while preparing for administration. Caller also reported that tip caps do not securely thread on to luer-lock adaptor. Caller stated the issue could also be associated with 25g 1" safety needles and will file PQC for needle products as well. No AEs reported, no additional PQCs.  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 was the lot number(s) on the product/carton? U035117 18-AUG-2023; U027357 25-MAR-2023 NOTE: This was needed to identify the needle supplied with the kit. NO NEEDLES SUPPLIED WITH KIT Please identify which part of the syringe needle was affected - NEEDLE ATTACHMENT, SYRINGE HUB Please provide a detailed description of the complaint defect. NEEDLES ATTACHED TO HUB SITE ARE FALLING OUT AND CAN NOT BE SECURELY ATTACHED; SYRINGE TIP DOES NOT SECURELY FASTEN TO HUB Under what situation was this defect noticed: (select one) If the syringe needle was not integrated into the syringe: Prior to removing the needle sheath? NO After removing the needle sheath? NO Prior to attaching the needle to the body of the syringe? NO While attaching the needle to the syringe? YES/NO/NA/UNSPECIFIED (if yes, describe) YES, UNABLE TO SECURE NEEDLE INTO HUB While giving the injection? YES/NO/NA/UNSPECIFIED (if yes, describe) NO After the injection was given? YES/NO/NA/UNSPECIFIED (if yes, describe) YES, NEEDLE DISLODGED OUT OF HUB WHILE ATTEMPTINT TO SECURE SAFETY CAP AFTER INJECTION. If Syringe needle was integrated into the body of the syringe: N/A Prior to removing the needle sheath? N/A After remove the needle sheath? N/A While giving the injection? N/A After the injection was given? N/A If the complaint was for a dull needle: N/A 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? N/A Did you/the patient use an alcohol swab on the syringe needle? N/A 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? N/A Have you/the patient injected yourself/herself at this injection site before? N/A Did you/the patient insert the needle into the body at an angle of 45 to 90? N/A Did you/the patient draw blood into the syringe and need to reposition the needle without removing from the skin? N/A  How many times did you/the patient try to inject the syringe? (Note: The patient should only inject the syringe once) - N/A Was the product dropped? NO  Was the syringe tray intact and undamaged on receipt? YES If no, describe damage. N/A If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. Yes If no, describe damage N/A Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO If yes, describe N/A Was the product administered or exposed to patient's bodily fluids (i. e. biohazardous)? NO If complaint sample is not/cannot be returned, please provide reason: 1 SYRINGE CAN BE RETURNED FROM LOT #U027357 EXP. 25-MAR-2023. 2 SYRINGES FROM LOT #U035117 EXP 18-AUG-2023 WERE USED AND DISPOSED.  *If photos were available, ask the customer to send them UNAVAILABLE Retrieval Information:  Obtain product (& tray if possible). Ensure enough absorbent material was provided to prevent breakage.  NOTE: Vaccine Prefilled 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:  16-AUG-2022 14:30 PM: Attachment added. 16-AUG2022: Reported lot U027357 logged under 368614  16-AUG-2022: Second person reviewed. 16-AUG-2022 16:30 PM: Waiting for Retrieval Site from Quality-- See attachments 16-AUG-2022 16:30 PM: Attachment added. 17-AUG-2022 11: 30 AM: Attachment added. 17-AUG-2022 12:30 PM: Labels created 17-AUG-2022  18-AUG-2022: Upon review, both Patient Code & Device Code fields were updated. 18-AUG-2022: Second person review performed.  Complaint Description Summary HCP users have had difficulty screwing safety needles into syringe hubs and needles do no securely stay in place and the needle dislodged from the syringe hub. ; Sender's Comments:  US-009507513-2208USA007610: