Catalog Number 20059E-0006 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd alaris smartsite extension set experienced tubing that ballooned.The following information was provided by the initial reporter: the patient required ct with contrast.It was relayed to the radiology department that the patient had extension tubing insitu.When patient attended imaging the extension could not hold the volume of fluid and exploded.The extension was removed and the fluid continued via the bung.Pt escorted to ct.Contrast attempted with pivc extension unable to handle pressure and explosion of extension line -nil harm to pt.Bung applied with ct/radiology supply of bungs and female style connection (concaved) rather than flat with pivc patent and nil concerns.
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Manufacturer Narrative
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Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Manufacturer Narrative
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H.6.Investigation: a 20059e-0006 product was not available for investigation; and the lot number of the affected product was not provided.As part of the investigation, the customer provided a photograph of the affected sample; analysis of the photograph identified that the tubing of the 20059e-0006 sample had burst during contrast injection.The details of this feedback were forwarded to the manufacturing site for investigation.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.Please note the 20059e-0006 set is validated to withstand pressures of up to 2 bar, if the product is subjected to pressures in excess of 2 bar it is possible for the reported leakage to occur.
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Event Description
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It was reported that the bd alaris smartsite extension set experienced tubing that ballooned.The following information was provided by the initial reporter: the patient required ct with contrast.It was relayed to the radiology department that the patient had extension tubing insitu.When patient attended imaging the extension could not hold the volume of fluid and exploded.The extension was removed and the fluid continued via the bung.Pt escorted to ct.Contrast attempted with pivc extension unable to handle pressure and explosion of extension line -nil harm to pt.Bung applied with ct/radiology supply of bungs and female style connection (concaved) rather than flat with pivc patent and nil concerns.
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Search Alerts/Recalls
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