Model Number IPN036127 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problems
Hematoma (1884); Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
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Event Date 12/06/2019 |
Event Type
malfunction
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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 the swg (spring wire guide) was stuck in the patient so the needle had to be entirely removed.Clinical consequences: it was impossible to insert the needle in the same vein, a hematoma appeared and loss of blood.A new device(s) was obtained for patient use.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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It was reported that the swg (spring wire guide) was stuck in the patient so the needle had to be entirely removed.Clinical consequences: it was impossible to insert the needle in the same vein, a hematoma appeared and loss of blood.A new device(s) was obtained for patient use.
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Search Alerts/Recalls
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