Sex: U
Vaccine: PNC13
Symptoms: Device issue, Needle issue, Product packaging quantity issue
Clinical narrative: an exposed needle; rubber tip cap was missing; There just wasn't enough vaccine fluid in it.; The initial case was missing the following minimum criteria: no adverse event only product complaint. Upon receipt of follow-up information on 08Mar2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: GD1174, Expiration Date: Mar2025) and as dose number unknown, single (Lot number: FY2984) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEEDLE ISSUE (non-serious), outcome "unknown", described as "an exposed needle"; DEVICE ISSUE (non-serious), outcome "unknown", described as "rubber tip cap was missing"; PRODUCT PACKAGING QUANTITY ISSUE (non-serious), outcome "unknown", described as "There just wasn't enough vaccine fluid in it.". Additional information: The product is a prefilled syringe. There just wasn't enough vaccine fluid in it. The nurse went to draw it up, and most of the syringe was close to the top. There was only a little left in it. Another nurse was in the room and confirmed none of the product leaked out into the needle. It was just this one syringe. The others have been okay. This has happened about a year ago with a different lot number, but she doesn't have that lot number. They just thought it was a fluke. No patient involvement. Packaging looks fine. They did their usual inventory check, and nothing was amiss at the time. Product Quality Group provided investigational results on 09Mar2023 for PREVNAR 13: As the lot number is unknown the scope of the investigation is limited to a review of the complaint profile for 'Product Container Under-Filled/Short Count' for Prevenar/Prevnar 13V. Regulatory Assessment; Following completion of the investigation a notification to the Regulatory Authorities is not required and the complaint is not related to manufacturing activities at Pfizer #. A Reserve Sample Inspection was not performed for this complaint as the lot number is unknown. A complaint sample was not returned for this complaint. A review of the trend profile for subclass 'Product Container Under-Filled/Short Count' for Prevnar 13V, and similar products Prevnar 20V, Apexxnar and Trumenba was performed over the past 3 years for all markets for this complaint. A trend was not identified for complaint subclass 'Product Container Under-Filled/Short Count'. Prior to release from the site the batch records are reviewed for compliance to current Good Manufacturing Practices, approved procedures and specifications and in accordance to the Marketing Authorisation (MA) requirements. All results must meet specification prior to batch disposition. Controls are in place to prevent/detect the reported complaint. The inspection machine has a 100% detection for underfilled and empty syringes. Following investigation no evidence was found to indicate the complaint occurred as a result of activities conducted at Pfizer #. Therefore the initial scope of the investigation did not change.No quality issues were identified. No issues impacting the identity, strength, purity or quality of the product were identified during the technical evaluation. No root cause or CAPA was identified as the complaint was not confirmed. A regulatory notification is not required. No further action is required. Product Quality Group provided investigational results on 23Mar2023 for PREVNAR 13: Conclusion: The complaint for "There just wasn't enough vaccine fluid in it" of PREVENAR 13V INJECTABLE was investigated. The investigation included reviewing an analysis of the complaint history for the product type and Annual Product Review. The final scope was determined to be the reported product and product type, as no lot was available. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. The site concludes that the reported defect is not representative of the Pfizer withheld process quality and remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Product Quality Group provided investigational results on 24Mar2023 for PREVNAR 13: Conclusion: The complaint for "There just wasn't enough vaccine fluid in it" of PREVENAR 13V INJECTABLE was investigated. The investigation included reviewing the involved batch records, deviation investigation, pictures of complaint sample, complaint sample, evaluation of retain sample, an analysis of the complaint history for the reported lot and product type and Annual Product Review. The final scope was determined to be the associated lot of the reported lot GD1174. The reported defect was present on the returned complaint sample and pictures. However the syringe showed signs of manipulation (plunger was pressed and a needle was attached). No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. The site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The  process determined that no regulatory notification was required. The reported defect could be confirmed on the returned complaint sample and pictures. No root cause or CAPA were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release. Product Quality Group provided investigational results on 29Mar2023 for PREVNAR 13: Summary of Investigation: Regulatory notification is not required for this complaint. The findings of the site investigation are as follows: Batch/Process Record Review: No Findings in relation to the reported complaint. There are controls in place to prevent/detect the reported defect, the inspection machine has 100% detection for under-filled and empty syringes. Reserve Sample Evaluation: No defects were observed related to the reported complaint. Complaint Sample Evaluation: The sample was not returned for the complaint. Update 27 Mar 23: The sample was evaluated at Pfizer (Site name withheld), refer to PR#8149779, the complaint was confirmed. The syringe had been manipulated. Trend/Complaint History: An evaluation of the complaint history confirms that this is the first complaint reported for the Fill Lot for this complaint subclass. A lot specific trend was not identified. A review of complaints for Subclass ' Product Container Under-Filled/Short Count' was performed for the last three years for Prevenar/Prevnar 13V , Prevenar/Prevnar 20v, Apexxnar and similar product Trumenba. A trend was not identified. The final scope was limited to the fill lot as no evidence was found to indicate that manufacturing activities at the site contributed to the reported complaint. Conclusion: This complaint reported 'Underfilled container' for a Prevnar/Prevenar 13v Syringe. The site Fill Lot is FY2984. The investigation included a review of; batch and process records, a lot history review, and a reserve review for the lot(s) in scope. The sample was evaluated at Pfizer (Site name withheld). The syringe did not contain the normal amount of suspension. No leaking was observed following a functionality test. The complaint was confirmed. 4 sample photos were received. The syringe did not contain a normal amount of suspension. The syringe had been manipulated. An evaluation of the complaint history confirms that this is the first complaint reported for the Fill Lot for this complaint subclass. A lot specific trend was not identified. A review of complaints for Subclass ' Product Container Under-Filled/Short Count' was performed for the last three years for Prevenar/Prevnar 13V , Prevenar/Prevnar 20v, Apexxnar and similar product Trumenba. A trend was not identified. There were no issues identified during the investigation impacting product quality. The complaint was confirmed but is not process related. A root cause was not identified, and no corrective/preventative actions are required. No biological report is required as the site have a 100% detection for underfilled and empty syringes. The syringe had been manipulated outside of Pfizer control. A regulatory notification is not required. No further action is required.  Follow-up (29Mar2023): This is a spontaneous follow-up report received from the product quality group. Updated Information included: investigation results and lot number.