Model Number IPN030899 |
Device Problems
Complete Blockage (1094); Material Twisted/Bent (2981)
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Patient Problem
Death (1802)
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Event Date 06/04/2020 |
Event Type
Death
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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: involving a covid-19 female patient that was in resuscitation department prior to the incident.During use, the distal catheter extension line twisted in/fold on itself.The infusion could not go through because of this issue so the doctor untwisted / unfold the extension line to make the infusion flow again.No medical intervention was necessary.The patient is deceased , but the customer clearly stated on the phone that the device did not contribute to the event because patient died from covid-19 few hours later.
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Manufacturer Narrative
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(b)(4).The customer returned one 2-lumen cvc for evaluation.The catheter body contained slight signs of use in the form of biological material.Visual examination of the catheter did not reveal any defects or anomalies.The extension lines did not contain creases or bends.The total length of the catheter body measured to be 215 mm which is within specifications of 207-227 mm per product drawing.The catheter was flushed using a water-filled lab inventory syringe.No leaks or blockages were detected.A lab inventory guide wire was able to pass through the returned catheter with minimal resistance.A device history record review was performed on the lot number reported (71f19k2279) with no relevant findings.The instructions-for-use provided with this kit warns the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the customer report of blocked/kinked extension lines could not be confirmed by complaint investigation of the returned sample.The sample passed all relevant visual, dimensional, and functional testing.A device history record review was performed with no relevant findings.No problem was found with the returned sample.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: involving a covid - 19 female patient that was in resuscitation department prior to the incident.During use, the distal catheter extension line twisted in/fold on itself.The infusion could not go through because of this issue so the doctor untwisted / unfold the extension line to make the infusion flow again.No medical intervention was necessary.The patient is deceased, but the customer clearly stated on the phone that the device did not contribute to the event because patient died from covid - 19 few hours later.Several attempts were made to gather additional information from the customer; however, the customer has not responded.
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Search Alerts/Recalls
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