Sex: U
Vaccine: HEP
Symptoms: No adverse event, Syringe issue
Clinical narrative: No additional AE; RECOMBIVAX HB broke at the finger flange when administering the product to a patient.; The HBP notes that the flange broke in the HCP's hand during administration but no injuries occurred; This spontaneous report was received from a health business professional (HBP) regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 11-APR-2024, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX  HB) intramuscular injection (prefilled syringe), 5 microgram per 0.5 milliliter, at 0.5 mL/series administered for prophylaxis (lot # x006977, is a valid lot number for hepatitis b vaccine (recombinant), expiration date: 01-OCT-2025) and while the product was administered, the syringe broke at the finger flange. The patient was uninjured and received full dose (poor quality device used). No additional adverse event.  This is one of two reports received from the same reporter.  Complaint Description Detail  Staff called on behalf of  HBP  to  report  AE/PQC.  The HBP was contacted and  reports  that  a  syringe  of  hepatitis b vaccine (recombinant)(RECOMBIVAX  HB)  broke at the finger flange when administering the product to a patient. The HBP notes that the flange broke in the HCP's hand during administration but no injuries occurred.  The HBP notes that the patient  and  the  HCP  are  uninjured  and  the  patient  received  their full dose. The broken product is the only component that is able to be obtained at this point due to the disposal of the carton and usage of the  rest  of  the  vaccines.  Pictures of  the  broken  syringe  only  will  be  forwarded  to  the  Company.  Multiple patient  AE  case number. No additional AE/PQC.  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: o~Is there a crack? NO o~If yes, describe the size, shape & depth of the crack: N/A o~Provide the exact location of the crack on the syringe:N/A   o~Is the syringe broken into 2 or more pieces? NO o~If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) N/A o~Provide the exact location of the breakage on the syringe? N/A   o~Does  the  syringe  have  a  broken  component?  CES  (e.g.  broken  syringe  tip;  loose  or  detached  luer  lock,  or  broken  finger flange , finger flange back-stop) FINGER FLANGE o~If yes, describe in detail how it is broken. BROKEN IN TWO OR MORE 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. N/A o~Was  the  syringe  needle  attached  or  being  attached  to  the  syringe  tip  when  the  issue  or  breakage  was  noted  or  occurred? YES o~If the issue involves the Syringe Needle or attachment issues: o~Was the Needle supplied by Merck? N/A o~Identify the Brand and Type of needle that was used: (e.g. BP, Safety needle/Blunt Needle etc.)N/A o~What was the Size and Gauge of the needle (e.g. 25g, 5/8 in) N/A o~Was anyone injured as a result of the breakage? NO o~If yes, provide brief description of injury N/A o~Note to CSR: Report an AE if yes as outlined in Instruction section   o~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? N/A o~Is there any broken glass or other separated component in the tray? (if yes specify)N/A   o~After removing the syringe from the tray? NO   o~While trying to attach the needle to the syringe? NO   o~While giving the injection? YES   o~Immediately after giving the injection? NO   o~Was the syringe tip cap attached properly prior to use? YES o~If no, describe issue: N/A   o~Was the syringe tray intact and undamaged on receipt? YES o~If no, describe damage. N/A   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 N/A  o~Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO o~If yes, describe N/A  o~Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES   o~If complaint sample is not/cannot be returned, please provide reason: COMPLAINT SAMPLE CAN BE RETURNED  ORDER NUMBER ( COPY OF INVOICE CAN NOT BE OBTAINED) Retrieval Information: o~Obtain~Defective~syringe~(broken~or~cracked),~unused~syringes~within~the~carton,~carton,~and~trays~(both~trays~within~the carton) -Document what can be retrieved in case description and/or notes BROKEN SYRINGE IS THE ONLY COMPONENT THAT IS ABLE TO BE OBTAINED o~Expedite return for cracked syringes. If there is a doubt whether it is cracked or broken, please expedite.  NOTE: Vaccine Prefilled Syringes including Sterile Diluent 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   15-Apr-2024 16:31 PM :Attachment added to Service Cloud.   15-Apr-2024 16:31 PM :Attachment added to Service Cloud.   15-Apr-2024 16:31 PM :Attachment added to Service Cloud.   15-Apr-2024 16:31 PM:E-mail received in~the~Contact~Center~mailbox~on~15APR2024 at~2:56 PM~with~picture~for~this case. See attached. Because picture is embedded in the e-mail it will be attached as PDF for viewing.  15-Apr-2024 16:31 PM :Attachment added to Service Cloud.   15-Apr-2024 16:31 PM :AE/PQC follow up: Only one syringe was reported as broken.   15-Apr-2024 18:00 PM :No further information was provided for this case.  16-Apr-2024 Picture~received~from~via~email~(along~with~other~case~attachments)~on~16-Apr-2024 is attached with the record. -~The  complaint  narrative  states,  'The  HBP  was  contacted  and  reports  that  a  syringe  of  hepatitis b vaccine (recombinant)(RECOMBIVAX  HB)  broke  at  the  finger flange when administering the product to a patient'. -~With~reference~to~provided~picture~and~complaint~narrative,~the~defect~is~categorized~under~PQC~category~'Broken~Syringe~> Flange - Broken During or After injection (Secondary Packaging)'. Note:  Answer  'Yes'  to  script  question  'Under  what  situation  was  this  defect  noticed:  While  giving  the  injection?'  supports  the PQC category selected for this record. -As  per  narrative,  photos  of  the  broken  syringe  are  only  available.  Also,  broken  syringe  is  the  only  component  which  can  be obtained.    On 16 -APR-2024: Second person review done   On 16 -APR-2024 10:01 AM :Attachment added to Service Cloud.   On 16 -APR-2024 10:01 AM :Awaiting retrieval site from Quality -- See Attachment   On 16 -APR-2024 12:00 PM :Attachment added to Service Cloud.   On 16 -APR-2024 12:00 PM :Retrieval site.   On 16 -APR-2024 12:00 PM :"labels created. o~Shipped on 04/16/2024. Tracking Numbers: o~Outbound o~Return Complaint Description Summary  PQC - The HBP was contacted and reports that a syringe of hepatitis b vaccine (recombinant)(RECOMBIVAX  HB) broke at the finger flange when administering the product to a patient.