The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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H3 evaluation summary: the device history record (dhr) cannot be reviewed because the lot number is unknown.The manufacturing site received one syringe sample in an opened package.A complete investigation was performed.Visual inspection to the quality inspection standard (qis) was conducted.A large plastic string was identified on the inside diameter of the syringe barrel.The plastic string was loose inside the syringe barrel and was visible on the face and side of the rubber tip and extended between two of the ribs of the plunger rod.The most probable root cause for the plastic string is determined to have been introduced into the syringe during the assembly process.There is a potential for plastic strings to originate during the transport of the molded components, including the syringe plunger, from the molding machines to the assembly process.Blow over tubes are cleaned and inspected at prescribed intervals.Visual inspections are performed throughout the length of each production run and in the event issues such as particulate are identified, corrective actions are performed to eliminate the source.Per procedure, complaint trends are evaluated during the monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.At this time, there is not enough information and a capa will not be initiated.However, these conditions will be communicated to the appropriate manufacturing and quality assurance personnel through a quality alert.
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