Sex: U
Vaccine: HEPA, HEPA
Symptoms: Physical product label issue, Syringe issue
Clinical narrative: The part where you put your fingers on is broken off the rest of the syringe / Sterile Injectable;N/A;Broken SyringeSterile Injectable;Primary Label;Missing Label; (one syringe does not have a label); "Missing  Label"; No patient involved; Transferred stating that 2 vials of VAQTA arrived "broken" without any additional information. No additional AE details or PQC.  THIS REPORT CAME HAND FROM AN EMPLOYEE. THEY DID NOT HAVE ANY OTHER ACCOMPANYING INFORMATION THAN WHAT WAS PROVIDED. AN OUTBOUND CALL WILL BE MADE TO CUSTOMER TO OBTAIN FURTHER DETAILSINFORMATION THAN WHAT DETAILS.  QUESTION SECTION: If vial is broken (Medium + Risk):  Broken Vial: A broken vial will have a piece of glass broken out of the vial or the vial will be broken into 2 or more pieces. Cracked Vial: -A cracked vial has a line or chip in the glass, but the vial is essentially intact in one piece. A vial is considered broken when the vial is in 2 or more pieces. -A vial 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 removing a flip cap or injecting diluent).  The damage was noted under what conditions? (select one from below) Upon opening the carton?  YES/NO/NA/UNSPECIFIED While removing the Flip cap? YES/NO/NA/UNSPECIFIED While withdrawing the product into a syringe? YES/NO/NA/UNSPECIFIED While injecting the diluent  from syringe into a vial? YES/NO/NA/UNSPECIFIED Other (describe)  Where is the location of the damage for each affected vial? (i.e. neck, shoulder, body or base of vial)  Describe the damage for each affected vial. (e.g., jagged edge, clean break, a hole, chipped etc.)  Is there broken glass in the carton? YES/NO/NA/UNSPECIFIED Does the carton or label appear wet at this time? YES/NO/NA/UNSPECIFIED  Does the carton or label appear lo have been wet in the past but now dried? YES/NO/NA/UNSPECIFIED (describe)  Was there any product remaining in the broken vial? YES/NO/NA/UNSPECIFIED If yes, what does ii look like (describe & include the color) (e.g. drops of liquid, condensation or dried yellow residue etc.)? If a liquid product, how much liquid remains? (suggest the amount is described in terms of where the liquid falls in relation to label or other landmarks).  Is the vial from a single vial carton or a multi-vial carton or tray (10x (ten-by) carton)? If multi-vial carton or tray, where was the affected vial(s) located in the carton? (e.g., first row, first on left side).  Was the vial's carton found to be damaged upon receipt? YES/NO/NA/UNSPECIFIED If yes, please describe the appearance of the carton, (ripped, unglued, crushed)  Was the product stored in its original carton after ii was received or removed from its carton and stored with other vials? (specify which)  Was the shipping container/Styrofoam shipper damaged upon receipt? YES/NO/NA/UNSPECIFIED If yes, describe damage in detail: Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES/NO/NA/UNSPECIFIED If complaint sample is not/cannot be returned, please provide reason: *If pictures may help, ask the customer to send them  Retrieval Information: Retrieve NOTE: Vaccine vials (MMR-II, PNEUMOVAX 23, VATQA, RECOMBIVAX, GARDASIL/GARDASIL 9, VARIVAX, PROQUAD, PEDVAX, ZOSTAVAX), and Antivenin/Normal horse serum vials that are considered biohazardous may be returned to Merck.  ASSOCIATED ARTICLES SECTION: Addi Info Sterile Vial Photo Descriptor Addi info Product Retrieval Process Guide Sample Tracking Number: User's Experience: Unknown Insertion Difficulty: Insertion Difficulty Details: Doubt About Presence: Doubt Details: Migration: Migration Details: Removal Problem: Removal Problem Details: 26-SEP-2022 18:30 PM :Outbound call placed to customer. Phone number, hours of operation and case number provided for callback. Upon callback, please gather any additional details for PQC including notes questions and information for a replacement. Also, determine if product available for replacement.   26-SEP-2022 18:30 PM :QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange.  Notes for DPOC:  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. 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). Please provide a detailed description of the defect using the questions below: Is there a crack? NO If yes, describe the size, shape & depth of the crack: NA Provide the exact location of the crack on the syringe: NA Is the syringe broken into 2 or more pieces? YES If yes, describe in detail how it is broken: "The part where you put your fingers on is broken off the rest of the syringe" Provide the exact location of the breakage on the syringe? "top portion, where your fingers rest on the syringe" Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) If yes, describe in detail how it is broken. "The part where you put your fingers on is broken off the rest of the syringe" Provide the exact location of the breakage on the syringe? "top portion, where your fingers rest on the syringe" Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO Was there difficulty trying to attach the syringe needle to the syringe? N/A If yes, describe N/A If yes, was it supplied by MERCK: N/A If not supplied by MERCK, what type & brand, needle size & gauge was used?' N/A Under what situation was this defect noticed: (select one) While the syringe was still in the tray? YES If yes, is there product (liquid or dried residue) in the tray? NO Is there any broken glass or other  SEParated component in the tray? Unknown by reporter After removing the syringe from the tray? N/A While trying to attach the needle to the syringe? N/A While giving the injection? N/A Immediately after giving the injection? N/A Was the syringe tip cap attached properly prior to use? N/A If no, describe issue: N/A  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. Unknown by Reporter If no, describe damage N/A Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO If yes, describe 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: *If photos are available, ask the customer to send them Retrieval Information: Obtain product (& tray if possible) Expedite 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. 26-SEP-2022 18:30 PM : Inbound call received from the customer. Caller reports the one to first notice the broken prefilled syringes of VAQTA, but was able to answer most of the PQC questions for this case. Caller is reporting 2 syringes of VAQTA were noted to be receipt, and stated that the breakage is where the finger placement should be when administering the vaccine. At the call the customer was unable to provide lot/exp date but stated that she will submit pictures of affected syringes to the email and include lot/exp date on the email. This agent requested that she place the syringes aside for retrieval. No additional information provided. No AE reported. No additional PQC reported.  26-SEP-2022 18:30 PM :Attachment added. 26-SEP-2022 18:30 PM :Email received on 26- SEP-2022 at 4:36 PM with pictures related to this case. The pictures were embedded with the email , so they were saved within a PDF file and attached. See attachments. 26-SEP-2022 18:30 PM :Attachment added. 26-SEP-2022 18:30 PM :Attachment added. 27-SEP-2022; Company Employee; Please ask caller to turn syringe around so we can retrieve the lot number form the label. Also, the second photo is a syringe with no label, is that a Merck syringe and was it received with a label? thank you 27-SEP-2022 09:30 AM :Attachment added. 27-SEP-2022 10:30 AM :Attachment added. 27-SEP-2022 10:30 AM :Email received on 27-SEP-2022 at 7:54 AM from Quality with the following request: Please ask caller to turn syringe around so we can retrieve the lot number form the label. Also, the second photo is a syringe with no label, is that a Merck syringe and was it received with a label?" See attached. Forwarded to case owner for follow up. 27-SEP-2022; Company Employee; Based on photo (one syringe does not have a label); "Missing Label" has been added to the PQC categories pending clarification if the syringe was received that way. 27-SEP-2022: Second person review performed by Company Employee 27-SEP-2022 13:30 PM :Outbound call placed to the customer to obtain lot/exp date and inquire if the second picture of the prefilled syringe is a Merck product. If it is a Merck product quality would like to know if it came with no label. This agent was unable to speak to the customer directly and left a VM to call back and referenced this case number. When the customer calls back please verify the lot/exp date for VAQTA and ask about the syringe in picture #2 that was emailed as this syringe did not have label and quality needs to identify if this is a Merck product and if so, which without the label. No AE reported. No additional PQC reported. 27-SEP-2022 14:30 PM :Waiting for Retrieval Site from Quality--See attachments 27-SEP-2022 15:30 PM :Attachment added. 27-SEP-2022 16:30 PM :Labels created 09/27/2022  27-SEP-2022 20:30 PM :-Per customer's email attached on 26-SEP-2022, product lot #W002889, Exp. date: 06-MAR-2023 28-SEP-2022 Company Employee; Updated the Lot Number field based on f/u with reported lot W002889. 28-SEP-2022: Second person review performed by Company Employee 30-SEP-2022: Company Employee - Attached email  03-OCT-2022; Company Employee; Please follow up on this response: 27- SEP-2022 13 :30 PM :Outbound call placed to the customer to obtain lot/exp date and inquire if the second picture of the prefilled syringe is a Merck product. If it is a Merck product quality would like to know if it came with no label. This agent was unable to speak to the customer directly and left a VM to call back and referenced this case number. When the customer calls back please verify the lot/exp date for VAQTA and ask about the syringe in picture #2 that was emailed as this syringe did not have label and quality needs to identify if this is a Merck product and if so, which product is it and was it received without the label. No AE reported. No additional PQC reported.  03-OCT-2022 14:30 PM :Attachment added. 03-OCT-2022 14:30 PM :Email received on Mon 03-OCT-2022 12:02 PM from Quality team for follow up. Please see attached email which is forwarded to case owner: Please follow up on this response: 27-SEP-2022 13:30 PM :Outbound call placed to the customer to obtain lot/exp date and inquire if the second picture of the prefilled syringe is a Merck product. If it is a Merck product quality would like to know if it came with no label. This agent was unable to speak to the customer directly and left a VM to call back and referenced this case number. When the customer calls back please verify the lot/exp date for VAQTA and ask about the syringe in picture #2 that was emailed as this syringe did not have label and quality needs to identify if this is a Merck product and if so, which product is it and was it received without the label. No AE reported. No additional PQC reported". 03-OCT-2022 14:30 PM :Outbound call made to customer. Customer stated it is not known whether the product came without a label or if it was removed and will "follow up." No additional PQC details or AE.