Sex: U
Vaccine: PNC13
Symptoms: No adverse event, Syringe issue
Clinical narrative: syringe broke; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 07Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Other Health Professional) from medical information team and product quality group.   A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) (Lot number: EC6448, Expiration Date: 30Apr2023) as dose number unknown, single for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "syringe broke". Additional information: They were preparing a syringe of Prevnar 13 when the syringe broke. The luer lock portion between the syringe and the needle broke off. The luer lock stayed attached to the needle and broke from the vial. Investigational results from Product Quality group on 04Mar2022 for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) Lot-#: EC6448, Expiration date: 30Apr2023. Brief Complaint Description: Brief Complaint Description: They were preparing a syringe of Prevnar 13 when the syringe broke. The luer lock portion between the syringe and the needle broke off. Reasonably Suggest Device Malfunction was Yes. Severity of Harm: S3. Conclusion: Severity has been corrected to S3. Additional review of the Annual Product Review is now required. The complaint for "it got broken" of Prevenar 13V Injectable was investigated. The investigation included reviewing the involved batch records, deviation investigation, pictures of complaint sample, evaluation of retain sample and an analysis of the complaint history for the reported lot and Product Review. The final scope was determined to be the associated lot(s) of the reported lot EC6448. 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. PGS withheld concludes that 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 report 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. Lot Trend Assmt. & Rationale: The complaint history has been reviewed for the reported batch. As no other complaints have been received in the past three years, no lot trend signal could be noticed. Other Trend Assmt. & Rationale: A complaint trend signal was identified. The Agency was consulted and the occurrence in the HA was compared with the complaint rate of this trend signal (occurrence: Moderate, (10-100); complaint rate: 0,75). No actual trend could be identified, and no actions are required. Complaint Sample Evaluation: (Parent) Sample Status: Sample Availability Unknown; Site Sample Status: Received at the Site.  Return Sample Evaluation: One syringe received. No defects were found on the label. There was about 3mm of normal looking homogeneous suspension after shaking left in the syringe. The rubber tip cap and the needle were missing. The rubber plunger was in position after ejecting part of a dose and the plunger rod was firmly attached. The tip had broken off and was missing. The luer lock was loose. Sample Condition: Confirmed Complaint Sample Defect: Yes  No follow-up attempts are possible. No further information is expected.