Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Exposure via eye contact, Eye pain, Syringe issue
Clinical narrative: eye pain; the medication squirted out of the syringe and got on patient's eyes and face; the medication squirted out of the syringe and got on patient's eyes and face; the leakage seems to be coming from syringe's mouth/opening area but the syringe looks to be intact and no visible cracks are seen; Was there difficulty trying to attach the syringe needle to the syringe? YES; during PNEUMOVAX 23 administration today, the medication squirted out of the syringe; during PNEUMOVAX 23 administration today, the medication squirted out of the syringe; Patient Details: Patient Age: 65 year-old Patient Gender: Female ------------------------- Case Additional Information: Concomitant Medication: No additional details available Pertinent Medical History: No additional details available Drug Reactions/Allergies: No additional details available ------------------------- Primary Product Identification: Primary Product Name: pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) INJ 1DS X 10 SYRINGES 00006483703 ------------------------- Product Details #1 (Primary Product) : Product Name: pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) INJ 1DS X 10 SYRINGES 00006483703 Dose Frequency: 1 dose Product Qty: 1 Lot Number: U027357 Expiration Date: 25MAR2023 Obtain: True Hazardous Product?: True  ------------------------- Adverse Event Details: Description: Caller is a medical assistant who stated that during pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) administration today, the medication squirted out of the syringe and got on patient's eyes and face. Patient has complained of eye pain but is managing symptoms by 'dabbing" on the eyes. Caller stated the leakage seems to be coming from syringe's mouth/opening area but the syringe looks to be intact and no visible cracks are seen. The syringe safety device is activated.  Prior date of patient's pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) dosing  was November 2011. Patient also received PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) in August 2020.   Product available for return. No additional AE/PQC details are available. Lab Diagnostics/Studies Performed: No additional details available Indication: Routine vaccination Route of Administration: IM Therapy Start Date: November 2011 AE Onset Date/Date PQC First Identified: 03-JUN-2022 Recovery Date: recovering Sought Medical Attention: Yes Was Treatment given for AE?: Yes Treatment Provided: Supportive therapy of "dabbing at the eye". No other treatment provided yet Present Status: Recovering from eye pain ------------------------- PQC Details: PQC Present?: true Priority: High Risk Operator of Device: Health Professional User Experience: Repeat User QIR Requested?: False ------------------------- Notes: Note: Attachment added. CreatedDate: 03-JUN-2022 20:39:04  Note: Attachment added. CreatedDate: 03-JUN-2022 20:36:33  Note: Email received in the mailbox on 3-JUN-2022 at 3:47 pm with pictures associated with this case. Saved email as PDF as the pictures were embedded within the email. See attachment. CreatedDate: 03-JUN-2022 20:03:54  Note: Attachment added. CreatedDate: 03-JUN-2022 20:02:03  Note: QUESTION SECTION:   Medium Risk:  Broken Syringe Barrel High Risk:  Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.   Notes for DPOC:  o A cracked syringe has a line or chip in the glass, but the syringe is essentially intact in one piece. A syringe is considered broken when the syringe is in 2 or more pieces. o A syringe is also considered "cracked" if it appears to be intact with evidence of a chip or crack OR appears to be intact initially but then breaks into 2 or more pieces during use (such as while attaching a needle or injecting diluent).  o Please provide a detailed description of the defect using the questions below:        oIs there a crack?  CALLER DOES NOT SEE A VISIBLE CRACK. WHEN TIGHTENING THE NEEDLE ONTO THE SYRINGE, CALLER STATED SHE "HEARD" A CRACK LIKE SOUND. WHEN SHE HEARD THE SOUND, SHE LOOSENS THE NEEDLE TO THE CORRECT POSITION.   oIf yes, describe the size, shape & depth of the crack: CALLER UNABLE TO VIEW CRACK  oProvide the exact location of the crack on the syringe: UNKNOWN TO CALLER        oIs the syringe broken into 2 or more pieces? NO  oIf yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) N/A  oProvide the exact location of the breakage on the syringe?  CALLER ASSUMES THE BREAKAGE WOULD BE AROUND THE MOUTH OF THE SYRINGE       oDoes the syringe have a broken component?  (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) CUSTOMER UNABLE TO CONFIRM AS CRACK IS NOT VISIBLE  oIf yes, describe in detail how it is broken.  oProvide the exact location of the breakage on the syringe? AROUND THE MOUTH  oIs the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO (if yes describe)      oWas there difficulty trying to attach the syringe needle to the syringe? YES  oIf yes, describe CALLER HEARD A CRACK SOUND WHEN ATTACHING THE NEEDLE  oIf yes, was it supplied by MERCK: NEEDLE WAS NOT SUPPLIED BY MERCK  oIf not supplied by MERCK, what type & brand, needle size & gauge was used?' 25GAUGE 1 INCHE NEEDLE. THE BRAND/COMPANY IS UNKNOWN.  oUnder what situation was this defect noticed: (select one)         oWhile the syringe was still in the tray? N/A  oIf yes, is there product (liquid or dried residue) in the tray? N/A  oIs there any broken glass or other separated component in the tray? (if yes specify) N/A   oAfter removing the syringe from the tray? N/A   oWhile trying to attach the needle to the syringe? YES   oWhile giving the injection? YES   oImmediately after giving the injection? N/A oWas the syringe tip cap attached properly prior to use? N/A   oIf no, describe issue: oWas the syringe tray intact and undamaged on receipt? YES   oIf no, describe damage. oIf the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed?  *See below. UNKNOWN TO CALLER         oIf no, describe damage N/A oWas the syringe carton damaged prior to use?  (i.e. crushed, ripped, unglued) UNKNOWN TO CALLER BUT THE CARTON SEEMS INTACT          oIf yes, describe oWas the product administered or exposed to patient's bodily fluids (i.e. biohazardous)?  YES oIf complaint sample is not/cannot be returned, please provide reason: UNIT IS AVAILABLE FOR RETURN *If photos are available, ask the customer to send them. CUSTOMER IS SENDING PICTURES  Retrieval Information:  oObtain product (& tray if possible) YES oExpedite return for cracked syringes. If there is a doubt whether it is cracked or broken, please expedite. NOTE:  Vaccine Prefilled Syringes may be returned even if biohazardous.  Complaint Description Summary Caller reported that the medication squirted out of the syringe and got on patient's eyes and face.