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 on 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 first device.
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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.Based on a review of applicable information, the following was concluded: the complaint of a damaged extension tube was determined to be inconclusive.One photograph of an arterial statlock was returned for evaluation.An initial visual observation of the photograph showed the statlock, extension tube, and the packaging side by side.There was a red square and arrow drawn around the junction of the extension tube and male luer connector.There were no distinguishing features on the sample in the returned photograph that could be used to identify a root cause of the alleged issue; therefore, the complaint is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.H3 other text: evaluation findings are in section h11.
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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 on 9/15: we have reviewed and, in every case, it is the same reported complaint ¿ the extension tubing spontaneously breaks/tears at the patient end of the tubing.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 first device.
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