Sex: U
Vaccine: PNC13
Symptoms: Syringe issue
Clinical narrative: When the nurse was pushing up the plunger to get the air out the top, the top snapped at the top, the lurer lock snapped off the body of the syringe part; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group for a sponsored program.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot number: EY0433, Expiration Date: 13Nov2023) as dose number unknown, single for immunisation. 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 "When the nurse was pushing up the plunger to get the air out the top, the top snapped at the top, the lurer lock snapped off the body of the syringe part". Additional information: NDC number of Prevnar 13 was 0005197101, a product issue where the head of the vial broke. No other issues with the syringes in that particular box. When they attempted to push air out of the top of the vial it broke. The product never was administered to a patient. Product Quality Group provided investigational results on 24Mar2022 for PREVNAR 13: This complaint for Prevnar 13V PFS Suspension 0.5 ML X 1 EA for when the nurse was pushing up the plunger to get the air out the top, the top snapped at the top, the lurer lock snapped off the body of the syringe part (possible broken glass), is a malfunction, if the event were to recur it could likely cause or contribute to death or serious injury. Product Quality Group provided investigational results on 01Apr2022 for PREVNAR 13: Reasonably suggest device malfunction was Yes; Severity of Harm was S3. Summary of Investigation: The 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. 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 "the top snapped at the top, the lurer lock snapped off the body of the syringe part" of "Prevenar 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. The final scope was determined to be the associated lot(s) of the reported lot "EY0433". 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. The reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification (BPDR) 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. Examination results: The package with 10 pre-filled syringes in a sealed blisters was checked visually. No defects could be observed. A functionality test has been performed on one of the syringes with 26G needle. No defects could be observed. The complaint history has been reviewed for the reported batch. As no similar complaints have been received in the past three years, no lot trend signal could be noticed. The samples were Received on 10Mar2022. Examination results: One Prevenar syringe received on site. The syringe was empty. The rubber tip cap was loose, the needle was present, the rubber plunger was in the position after ejecting a part of a dose and the plunger rod was firmly attached. There was dried up suspension inside the barrel. The tip was broken off in tip cap No other defects could be found. No evidence was found to indicate that manufacturing activities contributed to the reported complaint. The returned sample confirmed the complaint, A quality review of complaints reporting 'Broken tip' concluded that the root cause for this defect is due to an inherent weakness in the glass resulting from the syringe manufacturing process. Refer to RPT-128198 'Quality Assessment to review defect 'Broken Tip' in glass syringes for Prevnar/Prevenar 13V and Trumenba'. Complaints for this defect 'broken tip' are monitored, any required corrective actions will be documented. Refer to commitment tracking occurrence PR# 6516773. Impact Analysis: Following review of the investigation results based on the final scope, there is no evidence that manufacturing activities contributed to the reported complaint. A lot specific trend was not identified. The reported complaint is not representative of the quality of the batch and the batch remains acceptable. Breakages of this type (broken at the tip) are catastrophic and render the syringe unusable. The patient risk associated with this defect is marginal to low. Following investigation, no evidence was found to indicate that manufacturing activities contributed to the reported complaint, therefore no corrective and preventative actions were identified. Complaints for this defect 'broken tip' are monitored, any required corrective actions will be documented. Conclusion: This complaint reported a broken syringe tip for a Prevnar/Prevenar 13V syringe. The Lot is EM4747. Following investigation, the final scope was limited to the Fill Lot as a trend was not identified and no evidence was found to indicate that manufacturing activities 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. An evaluation of the complaint history identified no additional complaints reported for the Fill Lot for this complaint subclass. A lot specific trend was not identified, and a trend was not identified for the syringe barrel lots associated with the fill lot. A review of complaints for Subclasses ''Container Broken/Cracked/Leaking Prior To Use & Container Broken/Cracked During Prep/Use & Container Broken/Cracked/Leaking During Prep Use'' was performed for the last three years for Prevnar /Prevenar 13v& 20v, & Trumenba. A trend was not identified. No trends were identified . The complaint sample was received at Pfizer Puurs, the complaint was confirmed. A quality review of complaints reporting 'Broken tip' concluded that the root cause for this defect is due to an inherent weakness in the glass resulting from the syringe manufacturing process. Refer to RPT-128198, 'Quality Assessment to review defect 'Broken Tip' in glass syringes for Prevnar/Prevenar 13V and Trumenba'. The patient risk associated with this defect is marginal to low. The description for this complaint did not report any patient harm. There were no issues identified during the investigation impacting product quality. A process related root cause was not identified and no corrective/preventative actions are required. There are controls in place at Pfizer to prevent/detect this defect. The inspection machine has 100% detection for underfilled/empty syringes and also detects a missing tip cap and cracked barrel.  No follow-up attempts are possible. No further information is expected.