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 (Other HCP) from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) (Lot number: CY4766) as dose number unknown, single for immunization. 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. 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. Instructed to retain the product & it's packaging for possible quality investigation. Advised due to the Corona Virus Pandemic, the correspondence &/or Withheld package may be delayed in being sent. Packaging sealed and intact.  Product Quality Group provided investigational results on 07Oct2021 for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). Severity of Harm (Device) was S3. Sample Status was Requested. Photos were Available. Returned Sample Evaluation Summary: 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 position after ejecting part of a dose 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. The complaint of syringe tip broke when needle was being attached for Prevnar 13V PFS Suspension 0.5 ml x 1 EA was investigated by the manufacturing site. 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. Broken tip complaints are monitored by Name withheld in PR# withheld. As no probable root cause for the complaint could be related to the production process of Name withheld the complaint cannot be considered to be process related. Therefore no actions have been identified as a result of this investigation. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. Name 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. A report will be issued. Conclusion: 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 samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lots of the reported lot CY4766. 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. Name 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 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. Additionally, this complaint was also investigated by the Agency and they concluded that, based on the previous investigation of broken syringe tip, the root cause was identified to be related to the manufacturing of the glass syringes, resulting in inherent weakness in the glass. Agency# withheld classified the root cause as related to Material.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200475647 same reporter and event, different device