Sex: U
Vaccine: PNC13
Symptoms: Device breakage, Syringe issue
Clinical narrative: 2 Prevnar 13 pre-filled syringes broke when a staff member attempted to screw a needle onto the Prevnar 13 pre-filled syringes; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 25Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter (Nurse) from product quality group. A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (Lot number: DJ7720, Expiration Date: Sep2020) as dose number unknow, 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 "2 Prevnar 13 pre-filled syringes broke when a staff member attempted to screw a needle onto the Prevnar 13 pre-filled syringes". Additional information:  Registered Nurse reported she had 2 Prevnar 13 pre-filled syringes that broke when a staff member attempted to screw a needle onto the Prevnar 13 pre-filled syringes. She stated the whole collar broke off of the Prevnar 13 pre-filled syringe, where the needle screws into the Prevnar 13 pre-filled syringe. Reported their office purchased directly from Pfizer, and she was looking for a replacement or credit for the 2 broken Prevnar 13 pre-filled syringes. A sample of the product available to be returned, if requested.  Investigational results from Product Quality group on 16Mar2022 for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) Lot-#: DJ7720, Expiration date: 30Sep2020 Reasonably Suggest Device Malfunction was Yes. Severity of Harm: S3. Site Sample Status: Received at the Site: Return Sample Evaluation: One Prevenar syringe received on site. No defects found on label. The syringe was empty. The rubber tip cap was missing, the needle was missing, rubber plunger was in end position and the plunger rod was firmly attached. The tip of the syringe was broken off and missing. There was dried up suspension inside the barrel. Confirmed Complaint Sample Defect: Yes. Lot Trend Assmt. & Rationale: 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. Summary of Investigation: The (Withheld) 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. Broken tip complaints are monitored by Site. 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. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. (Withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. Conclusion: Updated on 09Mar2022 by #: Severity has been corrected to S3. Additional review of the Annual Product Review is now required. The complaint for "broken tip" of PREVNAR 13V INJECTABLE was investigated. The investigation included reviewing the involved batch records, deviation investigation, complaint sample, evaluation of retain sample(s), 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 DJ7720. 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 were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release. Broken tip complaints are monitored by Pfizer The complaint for "broken tip" of PREVNAR 13V INJECTABLE was investigated. The investigation included reviewing the involved batch records, deviation investigation, complaint sample, evaluation of retain sample(s), 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 DJ7720. 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. (Withheld) 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 were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021790924 same reporter and event, different device