C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number N/A |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/03/2024 |
Event Type
malfunction
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Event Description
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It was reported, "the patient was catheterized on (b)(6) 2024, during which he was regularly instilled, and no irritating fluid was infusion, and when the tube was flushed and sealed on (b)(6) 2024, it was found that there was fluid oozing from the puncture point, and the catheter was pulled out for examination, and it was found that the catheter had a longitudinal incision at 40cm." additional information received 03/12/2024: it was reported, "the event occurred in the patient's body.No skin swelling occurred.".
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Manufacturer Narrative
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H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.H3 other text : device not received.
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Search Alerts/Recalls
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