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Catalog Number 515303 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Chemical Exposure (2570)
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Event Date 04/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that leakage occurred with a bd preset¿ arterial blood collection syringe.The following information was provided by the initial reporter, "in a cisplatin infusion in a nacl 0.9% carrier solution with a volumen of 500 ml, the solution exited the infusion set due to the open tubing clamp through the access of the infusion device and cw (cytostatics) passed over to the nurse hands.Due to the cmr (cancerogen, mutagen, reproductionstoxic) potential of the substance there is a potential carcinogenic risk for the employee.
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Event Description
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It was reported that leakage occurred with a bd preset¿ arterial blood collection syringe.The following information was provided by the initial reporter, "in a cisplatin infusion in a nacl 0.9% carrier solution with a volumen of 500 ml, the solution exited the infusion set due to the open tubing clamp through the access of the infusion device and cw (cytostatics) passed over to the nurse hands.Due to the cmr (cancerogen, mutagen, reproductionstoxic) potential of the substance there is a potential carcinogenic risk for the employee.
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Manufacturer Narrative
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H.6.Investigation summary: no samples or photos of lot ta11163 were provided for investigation.A device history review was performed and found no non-conformances associated with this issue during the production of this batch.The final product for lot ta11163 is assembled and packaged at a supplier site.We have notified the supplier of the reported issue.Three retained samples from the reported lot were used for additional evaluation.There were no visual defects noted and the dimensional inspection verified the product was manufactured properly.Functional evaluations were conducted and in all cases the clamp performed as expected.Based on available information, since we were unable to duplicate the indicated failure mode and review of the device history records showed no indication of the alleged defect, we were not able to identify a root cause related to the manufacturing process at this time.A project has been initiated to enhance the design of the clamp, improving use and overall customer satisfaction with the device.Complaints for this device and defect will continue to be monitored by our quality team for signs of emerging trends.Conclusion: taking into account the complaints trend history (not related complaints with confirmed manufactured issues) and the kind of the reported issue (not related with the manufacturing process), the most probable root cause seems that the differences between the new c70 (manufactured in almaraz) and the previous c70 have not been clearly explained to the customers.A project has been opened to enhance the design of the claimed product.The primary change involves replacing the material of the current pinch clamp (made of polypropylene) by (polyoxymethylene), a stiffer material, enhancing the use and the customer satisfaction have been approved for the project implementation.H3 other text : see section h.10.
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Search Alerts/Recalls
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