C.R. BARD, INC. (BASD) -3006260740 STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION WITH STOPCOCK SET; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number N/A |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 09/06/2023 |
Event Type
malfunction
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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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been received by the manufacturer for evaluation.H3 other text : device not returned.
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Event Description
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It was reported by customer that the arterial statlock extension tubing spontaneously breaking.Additional information 9/15: we have reviewed and, in every case, it is the same reported complaint ¿ the extension tubing spontaneously breaks.Since this is an arterial line which is needed to monitor and treat critically ill icu patients, there is a significant bleeding risk to the patient.With these tubing breaks, patients have been found bleeding, had blood loss, delay in treatment due to needing to obtain and replace hemodynamic tubing and/or insert a new arterial line.No additional patient information is available nor relevant for these cases.It was reported this occurred with four devices.This report addresses the third device.
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Search Alerts/Recalls
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