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Model Number 8888160341 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the reported issue and root cause analysis.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.Manufacturing performs 100% leak testing as per procedure, which would identify this issue in the catheter assembly.No trends or triggers have been found; therefore, a corrective and preventive action is not deemed necessary at this time.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations.If additional information is obtained, or the sample is returned, this file will be re-opened for further investigation.This complaint will be used for qa tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The customer reported that while caring for the pre-term infant, the registered nurse (rn) noted the umbilical venous catheter (uvc) that was in place had a hole in the catheter.The rn stated that she was checking in on the infant when she noticed that the diaper went wet.Upon closer examination, she noticed fluid leaking from a hole in the line.The hole was located near the umbilical site, about 1/2cm from the umbilical.The line had been pulled back 3 cm about 30 minutes prior.The customer further reports that there were no clamps in use at the time and the rn stated that the catheter was not kinked.The neonatal nurse practitioner was alerted to the issue, and the catheter was removed.The premature infant was in the nicu, in an isolette on respiratory support.Was no harm determined in review of the event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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