Sex: U
Vaccine: HPV9
Symptoms: Product contamination physical, Syringe issue
Clinical narrative: Gardasil9 (10 syringes) had foreign material in them. FU: based upon the evaluation of the sample return, broken syringe has been added to the investigative PQC category; Gardasil9 (10 syringes) had foreign material in them. FU: based upon the evaluation of the sample return, broken syringe has been added to the investigative PQC category; No adverse event; Customer reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (10 syringes) had foreign matter in them. Caller reported that none of the syringes were administered to any patient's. Agent confirmed No AE involved. Please see additional PQC cases 02217989 (hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for 2 syringes) and PQC case 02217990 (Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX 23) for 12 syringes). No additional PQC reported. No further information was provided. Mailer was sent for product retrieval. filed in case 02218056.  QUESTION SECTION:   If foreign matter or particulate was INSIDE a prefilled syringe (Foreign Matter IS Potentially Touching Product) (High Risk)   Information to call handler:  Vaccine products containing alum (i.e. RECOMBIVAX, COMVAX, PedvaxHIB & GARDASIL 9) must be shaken well before use to re-suspend the alum back into solution (alum is seen as small white flecks prior to agitation & then becomes a homogenous slightly cloudy solution after agitation) o If the caller has not yet shaken the vial or prefilled syringe, please ask them to do so now. If the particulates still exist after agitation, then proceed to ask the appropriate PQC questions o If the particulate(s) are described as white flecks AND IF the white flecks dissolve back into solution after agitation and this is one of the products noted to be containing alum, then this would not be considered a PQC.  Please recode to the appropriate non-PQC product appearance article.  QUESTION SECTION:   o Describe the foreign matter. Try to obtain (with a reasonable attempt) a very specific description including:         o Color: White, moves with movement         o Number of particles: 1 LARGE CLUMP        o Size of particle: LARGE        o Shape of particle:  LARGE        o Texture: CAN'T DESCRIBE  o       Does the matter appear to be adhered to the inside of the syringe? YES         o If Yes: to what/where is the foreign matter attached? (e.g., stuck to the side of the syringe                 wall, the stopper? ---please be specific)  SIDE OF THE SYRINGE         o If No: does the matter appear to be suspended in the liquid? YES/NO/NA/UNSPECIFIED          o If yes, was the product agitated? YES          o If yes, for how long was the product agitated? UNKNOWN NOTE: Remember if the caller has not yet agitated the syringe, please ask them to do so now.   o Do the particulate(s) dissolve after agitation? NO        o If Yes: If the particulate(s) dissolve after agitation and if the particulates are described as                 white flecks and this is one of the products noted to be containing alum, then this would not                 be considered a PQC. Please recode to the appropriate non-PQC product appearance article.         o If No: Does it/they move freely with agitation? YES         o If Yes: does the particulate(s) sink quickly to the bottom after agitation stops or float within                  the liquid? (specify which) SINK QUICKLY TO THE BOTTOM  o Under what circumstance was the foreign matter/particulate found (select one):           o While still in the plastic tray? NO         o After removal from tray but before giving injection? YES         o During needle attachment? NA         o While giving injection? NA o OBTAIN PICTURES if possible - ask the customer to send them: CALLER WILL SEND THE PICTURES  Retrieval Information: Retrieve product - EXPEDITE Return - Foreign matter samples are needed ASAP to ensure that the foreign matter does not disappear. MAILER WILL BE SENT FOR PRODUCT RETRIEVAL o NOTE:  Vaccine Prefilled Syringes/vials may be returned even if biohazardous.   ATTACHMENT SECTION:  o Addl Info Product Retrieval Process Guide 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:  03-AUG-2022 at 14:30 PM :Attachment added.  03-AUG-2022,  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), Lot U008899 was logged under 367598.   Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX 23), Lot U027357 was logged under 367599.  03-AUG-2022: Second person review performed  03-AUG-2022 at 16:30 PM :Waiting for Retrieval Site from Quality-- See attachments  03-AUG-2022 at 16:30 PM :Attachment added.  03-AUG-2022 at 17:30 PM :Attachment added.  03-AUG-2022 at 18:30 PM :Attachment added.  03-AUG-2022 at 18:30 PM :Attachment added.  03-AUG-2022 at 18:30 PM :Email received on 03-AUG-2022 at 11:45 am with pictures for this case. Pictures were embedded in the email so saved and uploaded in a separate attachment. See attachments.  04-AUG-2022 at 13:30 PM :Labels created  04-AUG-2022    16-AUG-2022 at 12:30 PM :Outbound attempt made to the caller to check on the status of the mailer. Caller said she would send the defective product back. No AE/PQC reported.  19-AUG-2022, : Based upon the evaluation of the sample return, Broken syringe has been added to the investigative PQC category, hence the device reportability tab has also been updated along with  the Patient code, device code and reportability matrix.  19-AUG-2022 at 12:30 PM :Outbound attempt made to the caller to check on the status of the mailer. Unable to reach the caller. Agent left voicemail to call us back and reference the case number. No additional PQC reported. No AE reported.  19-AUG-2022 at 13:30 PM :Attachment added.  19-AUG-2022 at 13:30 PM :Email received on 19-AUG-2022 at 11:57am from quality stating: "This mailer was received today: 02217951". Based upon the email and confirming the return via the tracking number the mailer for this case has been returned. Product return date updated, and case closed.  19-AUG-2022: Second person review performed.  24-AUG-2022: Second person review performed.  25-AUG-2022,Based upon the new defect ( Broken syringe found in the evaluation of the sample return, EQA has now also been added as a lead. will composed a delayed memo to have an date extension completed for EQA  25-AUG-2022,Received & Attached photo.  25-AUG-2022: Second person review performed.  Complaint Description Summary  Customer reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (10 syringes) had foreign matter in them. 25-AUG-2022, F/U: Based upon the evaluation of the sample return, Broken syringe has been added to the investigative PQC category.