Sex: U
Vaccine: PNC13
Symptoms: Device breakage
Clinical narrative: found to be broken in the packaging; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 11Oct2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Physician) 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: FH9982, Expiration Date: 30Apr2024, NDC Number: 0005197102) for immunisation, Device Lot Number: FH9982, Device Expiration Date: 30Apr2024. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "found to be broken in the packaging".  Additional information: Doctor called in requesting a replacement for a single dose of Prev 13 that was found to be broken in the packaging. Doctor reported receiving vaccine back in Aug2022, did not  begin using it until mid Sep2022. At some point, one of the 10 vials was noticed to be broken, all other doses were fine and there was no damage to the package, they do not believe the damage happened onsite. A second section of prefilled syringes was opened, and one prefilled syringe was found to be broken. Of a total of 10 prefilled syringes, one was broken. The other 9 prefilled syringes were intact, and all the vials looked fine. Those 9 prefilled syringes that were intact were administered to patients. The one prefilled syringe that was broken was not administered to a patient. The doctor's medical assistant used the first package of 5 prefilled syringes. Then she opened the second package of 5 prefilled syringes, and she noticed one syringe was broken. The broken syringe was found when the package was opened. Broken syringe was not administered to a patient. Product strength and count size dispensed: 0.5ml/ two packages of 5 prefilled syringes, total of 10 prefilled syringes. Sample of the product is available to be returned, if requested. It was clarified that there was no patient involvement. 9 out of 10 doses within the package of single dose syringes were ok, were totally fine, not broken, and no cloudiness. Those were given to patients. One out of the 10 syringes was broken and put to the side. It was broken when they opened the package. There was no damage to the package, and all of the other vials were totally fine.  Investigation result received on 25Oct2022. The site investigation could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. All reviewed records for the involved batch indicated that the batch met the established requirements at time of release. However, without the complaint sample and based on the available information it is not possible to perform a more profound investigation and/or root cause analysis. Impact analysis # 24Oct2022. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. Site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. No corrective or preventive actions were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release. Conclusion: The complaint for "broken syringe was found when the package was opened" of Prevnar 13v Injectable was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of retain samples, 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 FH9982. 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. Site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of retain sample. No root cause or CAPA were identified as the complaint was not confirmed.  Investigation result received on 07Nov2022. Summary of Investigation: The initial scope of the site investigation is limited to the lot documented in the related lots grid. Following completion of the investigation it is determined that a regulatory notification is required for this complaint.\The findings of the investigation are as follows. Batch/Process Record Review: No Findings in relation to the reported complaint. Reserve Sample Evaluation: No defects were observed related to the reported complaint. Complaint Sample Evaluation: The complaint samples were received at Pfizer (site name), following sample evaluation, the reported defect was confirmed. Trend/Complaint History: A lot specific trend was not identified For the Fill Lot. A trend was not identified for complaints reporting a broken tip following a review of the syringe barrel lots used to manufacture the Fill Lot. Review of reports: A review of the three latest review reports was performed. The final scope was limited to the Fill Lot (refer to related lots grid) as no evidence was found to indicate that manufacturing activities at (site name) contributed to the reported complaint. Conclusion: This complaint reported a Broken Tip for a Prevnar/Prevenar 13V syringe. Note: The description of this complaint did not report any patient harm. The (site name) Fill Lot is FA5692. Following investigation, the final scope was limited to the site Fill Lot as a trend was not identified and no evidence was found to indicate that manufacturing activities at site contributed to the reported complaint. 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 complaint samples were received at Pfizer site, following sample evaluation, the reported defect was confirmed. An evaluation of the complaint history confirmed that this is the first complaint reported for this subclass for the Fill Lot. A lot specific trend was not identified. A trend was not identified for the syringe barrel lots associated with the Fill Lot for this class/subclass. Controls are in place to prevent/detect the reported complaint. The inspection machine has 100% detection for underfilled/empty syringes and also detects a missing tip cap and cracked barrel. Investigation found that the root cause for defect 'broken tip' is due to defects/flaws which occur during the syringe manufacturing process followed by subsequent mechanical stress leading to tip breakage. A contributory root cause identified that there is no standardised risk-based method for requesting vendor investigations from suppliers for defects reported in customer complaints. Corrective actions have been identified.  There were no issues identified during the investigation impacting product quality. A process related root cause was not identified at (site name). A vendor related root cause was identified. After assessment of the complaint, it was determined that a regulatory notification is required. Complaints for this defect 'broken tip' are monitored by site. Review of reports: A review of the three latest review reports was performed. No trends were identified for Broken syringe. No further action is required.  Investigation result received on 10Nov2022. Summary of Investigation: Update 09Nov2022: complaint sample received on 24Oct2022. The site investigation could not indicate a probable root cause for the complaint to be related to the packaging process of the involved batch (Pfizer site only performs packaging). All reviewed records for the involved batch indicated that the batch met the established requirements at time of release. Investigation by our particle characterization team indicated that a force was applied onto the side of the tip of the barrel. The area of origin of the broken tip was due to a scratch inside the barrel indicating that the glass barrel was weakened at that point. No corrective or preventive actions were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release. Addition by # on 09Nov2022. Impact assessment: No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability. Site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The site investigation could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. All reviewed records for the involved batch indicated that the batch met the established requirements at time of release. However, without the complaint sample and based on the available information it is not possible to perform a more profound investigation and/or root cause analysis. Impact analysis # 24Oct2022. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. Site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. No corrective or preventive actions were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release. Update 09Nov2022: complaint sample received on 24Oct2022. The complaint for "the broken syringe was found when the package was opened" of Prevnar 13v Injectable was investigated. The investigation included reviewing the involved batch records, deviation investigation, 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(s) of the reported lot FH9982. The reported defect was present on the returned complaint sample. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. Site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could be confirmed on the returned complaint sample. 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. The complaint for "broken syringe was found when the package was opened" of Prevnar 13v Injectable was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of retain samples, 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 FH9982. 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. Site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of retain sample. No root cause or CAPA were identified as the complaint was not confirmed.  The reporter considered "found to be broken in the packaging" associated to pneumococcal 13-val conj vac (dipht CRM197 protein). Follow-up attempts are completed. No further information is expected.