Catalog Number AW-04018 |
Device Problems
Difficult to Insert (1316); Material Deformation (2976)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 06/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Additional information requested regarding patient condition.No additional information received at the time of this report.
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Event Description
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Dr.Eka plaint to implant spring wire arrow for baby in nicu after open product look good but when try to insert into aximed 24 cannot inserted because guide wire feels rusty then doctor decided to change with new device batch 14f1880280 apparently same thing happens and procedure is stopped.
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Manufacturer Narrative
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(b)(4).The customer returned one swg and lidstock for evaluation.Visual inspection of the guide wire revealed one small bend in the body of the guide.Both the proximal and distal weld are intact.No other defects were observed on the swg.The small bend in the guide wire measured 180mm from the proximal weld.The overall length and outer diameter of the guide wire were measured and were found to be within specification.The guide wire passed through an inventory ars and introduction needle with minimal resistance.A manual tug test confirmed both welds are intact.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.The ifu provided with this wire warns the user "to minimize the risk of spring-wire guide damage withdraw catheter relative to spring wire guide about 2-3 cm and attempt to remove spring-wire guide.If resistance is again encountered remove spring-wire guide and catheter simultaneously." the report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire contained a small bend in the guide wire body.The returned guide wire met all relevant dimensional requirements and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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Dr.(b)(6) plaint to implant spring wire arrow for baby in nicu after open product look good but when try to insert into aximed 24 cannot inserted because guide wire feels rusty then doctor decided to change with new device batch 14f1880280 apparently same thing happens and procedure is stopped.
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Search Alerts/Recalls
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