Sex: U
Vaccine: HEP
Symptoms: No adverse event, Syringe issue
Clinical narrative: no adverse event; Sterile Injectable;N/A;Broken Syringe; HCP calling to report that one RECOMBIVAX HB syringe in a box of 10 was damaged. HCP states, "The yellow plunger, where you would put it into someone's arm, the plunger normally hits a circular disk and that circular disk piece on this one syringe is broken off. That part of the syringes is separated from the rest. The circular piece is hanging on the syringe now." HCP confirms that the defective syringe was NOT administered to any patient and is still in the tray. HCP confirms there was no damage to the box or tray. HCP confirms that the rest of the 9 prefilled syringes in the box of 10 that they received, were not damaged at all and administered to patients without issue. HCP confirms that this one Hepatitis B Vaccine (Recombinant) (thimerosal free) (Recombivax HB) PFS is available for retrieval in the original tray. HCP provided number as: 0006-4093-02. Please note: the one defective product was NOT administered to any patients therefore no AE is being filed. No additional PQC. SEE N-793387 for NOTE QUESTIONS/ANSWERS 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 16:30 PM :QUESTION SECTION: Medium Risk: Stuck or Loose;   Medium + Risk: Missing QC Prefilled Syringe Device Plunger Rod and Stopper Irregularity Plunger or Stopper Fell out Missing Stuck Loose Damaged Bent Broken Medium Risk: Stuck or Loose Medium + Risk: Missing     Which irregularity occurred: (select one below)         Plunger rod (only) fell out of syringe barrel during use or is loose? NA. The plunger rod is not loose. The stopper is loose.                 If the plunger rod fell out, confirm if the rubber stopper remained in the syringe barrel)  NA           Plunger rod & stopper fell out of syringe barrel during use or is loose? NO                 Plunger rod would not move? NA                         If yes, was resistance felt while pulling the plunger rod or pushing the plunger rod: (specify which)            Plunger rod missing, i.e. not in the tray? NO           Plunger rod & stopper missing? NO the rod and stopper is still present, however the stopper is not attached entirely to the syringe anymore.            Plunger rod appeared to move without being touched? NO           Plunger rod is damaged; bent; broken or discolored? NO           Syringe stopper is damaged, malformed or discolored? YES the stopper is damaged as it is not attached to the syringe completely anymore. No discoloration seen.   Under which situation was this defect noticed: (select one below)          While still in the tray? YES. Noticed when it was in the tray.          After removing the syringe from the tray &/or preparing the syringe for injection? NO                 If yes, describe what actions were occurring when the defect happened.         While giving the injection? NO. The product was not used on any patients.                  If yes, describe the actions occurring when defect happened or was noticed?  Was the syringe tray intact and undamaged on receipt? YES, and other four syringes in that 5 pack were fine.           If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *The product comes in a temp regulated styrofoam bin with bubble wrap. No cellophane cover that the reporter is aware of.           If no, describe damage  Was the syringe carton damaged?  (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:   NA  If photos are available, ask customers to send photos.   YES. Customer will email photos.   Retrieval Information:  Obtain product (& tray if possible) YES available for retrieval.    NOTE:  Vaccine Prefilled Syringes may be returned even if biohazardous.  16-AUG-2022 16:30 :Attachment added.  16-AUG-2022 17:30 :Waiting for Retrieval Site from Quality-- See attachments  16-AUG-2022 17:30 :Attachment added.  16-AUG-2022: Requested obtain photos if possible.  17-AUG-2022 10:30:Attachment added.  17-AUG-2022 10:30:Email received on 16-AUG-2022 at 18:46 from quality stating: "Pls. obtain photos if possible." See attached. Email forwarded to case owner for follow up  17-AUG-2022: The priority for this record has been changed per Product Quality Complaint, Complaint Category and Risk Priority Table.  17-AUG-2022: Date Due field updated to reflect 15-SEP-2022 17-AUG-2022;  Second person reviewed by reviewer A  17-Aug-2022 12:30 :Attachment added.     17-AUG-2022 14:30 PM :Customer called back (interaction 02227793) stating that she will have the HCP send the picture of the defective syringe by end of day most likely. Customer states she will have the HCP reference this case: 02227031. No AE, no additional PQC.  17-AUG-2022: Requested clarify with reporter the following:  Is the "circular disk piece" the round broken glass finger flange? Can it be clarified if only the round glass finger flange is broken off and loose, being held onto the syringe by the plunger rod? Is the gray rubber stopper that is inside of the syringe barrel loose? Does it appear to be properly seated?  Is the liquid still inside of the syringe?  17-AUG-2022 16:30:Attachment added.  17-AUG-2022 16:30:Email received on 17-AUG-2022  at 15:20 with the following request from quality: "Please contact reporter to clarify the following:  Is the "circular disk piece" the round broken glass finger flange? Can it be clarified if only the round glass finger flange is broken off and loose, being held onto the syringe by the plunger rod? Is the gray rubber stopper that is inside of the syringe barrel loose? Does it appear to be properly seated?  Is the liquid still inside of the syringe?" See attached. Forwarded to case owner for follow up.  18-AUG-2022: PHOTO received & attached  18-AUG-2022; Based on f/u from reporter that she will send picture of the defective syringe and photo received & attached, depicting the finger flange of  the syringe was only broken , hence, Loose Stopper has been removed from the Reported and Investigative PQC Categories.  18-AUG-2022: Second person review performed by reviewer B.  18-AUG-202214:30 :Per PQC notification email attached to this case, this agent placed outbound call to ask the following:  Is the "circular disk piece" the round broken glass finger flange? Can it be clarified if only the round glass finger flange is broken off and loose, being held onto the syringe by the plunger rod? Is the gray rubber stopper that is inside of the syringe barrel loose? Does it appear to be properly seated?  Is the liquid still inside of the syringe? Agent was informed by the office answering service that the office is closed on Thursdays. Agent will place another outbound call to customer on 19-AUG-2022 to attempt to ask clarifying questions above. No AE. No additional. PQC.  18-AUG-2022: Patient Code updated.  18-AUG-2022: Second person review performed by reviewer B.  18-AUG-2022: Attached f/u failure states: 18-AUG-2022 T13:39:10-04:00 "Per PQC notification email attached to this case, this agent placed outbound call to ask the following:  Is the "circular disk piece" the round broken glass finger flange? Can it be clarified if only the round glass finger flange is broken off and loose, being held onto the syringe by the plunger rod? Is the gray rubber stopper that is inside of the syringe barrel loose? Does it appear to be properly seated?  Is the liquid still inside of the syringe? Agent was informed by the office answering service that the office is closed on Thursdays. Agent will place another outbound call to customer on 19-AUG-2022 to attempt to ask clarifying questions above. No AE. No additional. PQC." 18-AUG-2022 T09:14:30-04:00 Email received on 17-AUG-2022 at 10:43pm with pictures related to this case. Pictures were embedded within email so pictures saved as PDF and attached separately. 18-AUG-2022 T09:14:30-04:00 Attachment added. 18-AUG-2022 T09:14:30-04:00 Attachment added.