C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Swelling/ Edema (4577)
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Event Date 03/11/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient had a groshong catheter implanted on (b)(6) 2022.The patient had a fever of over 39 ° c from the day the catheter was inserted, and the fever did not decrease even after 4 days.Therefore, the device was removed from the patient¿s body.Blood culture and catheter culture tests were negative.Ultrasonography and mri confirmed that the edema of the adipose tissue of the upper arm where the catheter was inserted was strong.After removing the catheter, the patient is gradually improving.There was no reported patient injury.
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Manufacturer Narrative
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The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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Search Alerts/Recalls
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