Submit date: 6-22-2018.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.If information is provided in the future, a supplemental report will be issued.
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Submission date: 09/06/2018.An investigation was performed for the reported customer complaint: ¿the customer reported the blue thread separates from the gauze and there is a risk that it stays in the patient.¿ the device history record (dhr) for the reported lot number 17k247362 indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.No sample was returned with this complaint.However, a sample was returned from the customer for a complaint of the same issue and product that was evaluated.Visual examination of all ten (10) sponges observed they were in an unfolded state.The finished product is produced in a folded state.From the unfolded state, the element is not loose on the sponges.From the unfolded state it is unconfirmed that the element is loose.The autobanding equipment that is used adds two x-ray detectable elements.These elements are heat bounded to the gauze, ensuring the element adheres to the gauze.The element tension, heater iron temperature, bonding wheel pressure, feed roll pressure, sponge machine speed, bonding wheel weight and bonding wheel rubber height are noted on the device history record (dhr) that all were within acceptable parameters.This complaint is not confirmed with the sample.A root cause could not be determined.This complaint will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
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