Sex: U
Vaccine: PNC15
Symptoms: Accident at work, Skin laceration, Syringe issue
Clinical narrative: Also, we took a picture of where the vaccine administrator was cut by the vaccine pieces.; Physician states that after administration of VAXNEUVANCE PFS, she noticed the finger flange had broken off and she believes it broke off during product administration; Also, we took a picture of where the vaccine administrator was cut by the vaccine pieces.; This spontaneous report was received from a physician regarding another health care professional (also reported as administrator) of unspecified age and gender. The patient's medical history, historical drugs, known allergies, concurrent conditions, nor concomitant therapies were not reported.  On 29-MAY-2024, the healthcare professional cut their finger tip (also reported as small injury to finger tip) with the pieces of a broken pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), 0.5 milliliter injection (INJ) 1 dose (DS) X10 syringes, lot #Y002963 (batch#0001716939), expiration date: 04-OCT-2026, vaccine, as the finger flange had broken and they believed it had been during the administration of this vaccine to the patient (Skin laceration, syringe issue, injury associated with device).  QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Is there a crack? NA o Is the syringe broken into 2 or more pieces? YES o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) BROKEN INTO PIECES o Provide the exact location of the breakage on the syringe? FINGER FLANGE o Does the syringe have a broken component? YES o If yes, describe in detail how it is broken. BROKEN IN MULTIPLE PIECES o Provide the exact location of the breakage on the syringe? FINGER FLANGE o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO o Is there difficulty attaching the Syringe Needle to the Syringe? NO o If Yes, describe the type of issue you are experiencing in detail. o Was the syringe needle attached or being attached to the syringe tip when the issue or breakage was noted or occurred? NO o If the issue involves the Syringe Needle or attachment issues: NA o Was anyone injured as a result of the breakage? YES o If yes, provide brief description of injury AFTER CALL, VACCINE ADMINISTRATOR SENT IN PHOTO THAT SHOWS SMALL INJURY TO THE FINGER TIP. CALLER DENIED ANY INJURY TO ADMINISTRATOR OR PATIENT DURING CALL (conflicting information). Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? NO o If yes, is there product (liquid or dried residue) in the tray? NO o Is there any broken glass or other separated component in the tray? (if yes specify) YES- CALLER BELIEVES IT IS PART OF THE BROKEN SYRINGE BUT CANT TELL IF IT WAS THERE PRIOR TO REMOVING THE SYRINGE OR AFTER o After removing the syringe from the tray? NO o While trying to attach the needle to the syringe? YES o While giving the injection? NO o Immediately after giving the injection? YES o Was the syringe tip cap attached properly prior to use? UNSPECIFIED o If no, describe issue: o Was the syringe tray intact and undamaged on receipt? YES o If no, describe damage. o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. YES o If no, describe damage o Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO o If yes, describe o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES  Difficult to obtain complete information as physician kept handing the phone off to her Medical Assistant throughout the call.  This case was non-valid due to the lack of patient identifiers. ; Sender's Comments:  US-009507513-2405USA009568:MSD