Catalog Number SAC-01218-PBX |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/18/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that "after the arterial catheter has been in place for 24 to 48 hours, no arterial pressure measurement is possible.Measurement curve very flat to no longer available.Device was placed into the radial artery; as a result, a new device was placed.".
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Manufacturer Narrative
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(b)(4).Corrected data: section d.1.- brand name corrected to arrow arterial cath set: 18ga x 12cm.Section d.4.- catalog# corrected to sac-01218-pbx.The customer returned one arterial catheter for evaluation.The catheter was returned with additional tubing secured to the proximal luer hub.Significant signs of use were detected within the extension line and interior of catheter body.Visual examination of the catheter revealed one prominent kink in the catheter body adjacent to the juncture hub.The kinked area appeared creased and discolored.The total length of the catheter body measured to be 124 mm which is within specifications of 122-126 mm per product drawing.The outer diameter of the catheter body measured to be 1.272 mm which is within specifications of 1.24 -1.30 mm per product drawing.The returned catheter was flushed using a lab inventory syringe.No blockages or leaks were observed.A lab inventory guide wire was able to advance through the returned guide wire with minimal resistance.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The instructions-for-use provided with this kit warns the user, "care should be exercised that the catheter is not inadvertently kinked at the hub area when securing catheter to the patient as this may result in catheter damage, breakage and loss of arterial monitoring capabilities." the customer report of a kinked catheter was confirmed by complaint investigation of the returned sample.The catheter contained one prominent kink in the catheter body.Bends and kinks in the catheter body can result in interference or loss of arterial monitoring capabilities.The returned sample passed all relevant dimensional testing and a device history record review was performed based on sales history with no relevant findings.Based on the condition of the sample provided, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
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Event Description
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It was reported that "after the arterial catheter has been in place for 24 to 48 hours, no arterial pressure measurement is possible.Measurement curve very flat to no longer available.Device was placed into the radial artery; as a result, a new device was placed.".
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Search Alerts/Recalls
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