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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The customer reports upon insertion of a 5 fr dual lumen uvc when physician aspirated for blood return from the vessel, it was noted that there were air bubbles coming into the syringe.Upon closer inspection of the line, there was found to be a small crack in the hub of the uvc catheter where the line connects to the microclave (of the primary, clear lumen) which is causing air to enter into the syringe with aspiration.The uvc line had to be removed from the vessel and a new double lumen uvc had to be placed with more difficulty than the initial attempt.
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An investigation was performed for the reported customer complaint: ¿the customer reports upon insertion of a 5 fr dual lumen uvc when physician aspirated for blood return from the vessel, it was noted that there were air bubbles coming into the syringe.Upon closer inspection of the line, there was found to be a small crack in the hub of the uvc catheter where the line connects to the microclave (of the primary, clear lumen) which is causing air to enter into the syringe with aspiration.The uvc line had to be removed from the vessel and a new double lumen uvc had to be placed with more difficulty than the initial attempt.¿ a review of the device history record (dhr) for lot no.1624400139 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.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.Manufacturing also performs 100% leak testing for this device, which would identify this issue in the catheter assembly process.Analysis concluded there were no assembly component related issues.One (1) argyle polyurethane umbilical vessel catheter was received for evaluation.The visual inspection of the returned product noted no abnormalities.Functional testing was performed by submerging the catheter into a water bath.The end was clamped and a syringe was used to inject air to observe leakage.No air bubbles were present.Both extensions were tested with acceptable results.The investigation was unable to determine a root cause or establish a relationship between the device and the reported incident.No enhancements or improvements were generated for the reported condition.The reported customer complaint is not confirmed.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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