C.R. BARD, INC. (BASD) -3006260740 STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION SET 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number N/A |
Device Problems
Fluid/Blood Leak (1250); Defective Component (2292)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 01/24/2024 |
Event Type
Injury
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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 manufacturer has received the sample and will evaluate.Results are expected soon.
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Event Description
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It was reported by customer that the product is cracked.It appears to be the extension tubing itself which would be different than the statlock devices which would go over the tubing and hub.Leaking stat-lock arterial line device.Newly inserted arterial line stat-lock device noted to have blood backing up and leaking on pillow.Upon switching to new line, noted crack in tubing where blood was leaking from.Product issue with cracking causing blood to back up into tubing, inaccurate blood pressure, switched to new stat-lock with no issues.It was reported this occurred with two devices.One device was used on a patient and one was not used on a patient.This report addresses the device that was used on a patient.
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Event Description
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It was reported by customer that the product is cracked.It appears to be the extension tubing itself which would be different than the statlock devices which would go over the tubing and hub.Leaking stat-lock arterial line device.Newly inserted arterial line stat-lock device noted to have blood backing up and leaking on pillow.Upon switching to new line, noted crack in tubing where blood was leaking from.Product issue with cracking causing blood to back up into tubing, inaccurate blood pressure, switched to new stat-lock with no issues.It was reported this occurred with two devices.One device was used on a patient and one was not used on a patient.This report addresses the device that was used on a patient.
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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.
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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 complaint of a leak in the extension set tubing was inconclusive due to the sample condition.Two photographs of the arterial statlock kit (art0420) were provided.The provided photographs showed the product type that was included in the affected medline ynhh arterial line insertion bundles.These photographs were not of the affected products and no damage was apparent in the returned photographs.There was reference in the email attachments to other photographs of the affected product.However, these photographs were not attached to the complaint file and therefore could not be evaluated at this time.In addition, physical samples were sent to medline and therefore, bd does not have access to these samples for evaluation.This complaint will be recorded for future trending and monitoring purposes.
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Event Description
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It was reported by customer that the product is cracked.It appears to be the extension tubing itself which would be different than the statlock devices which would go over the tubing and hub.Leaking stat-lock arterial line device.Newly inserted arterial line stat-lock device noted to have blood backing up and leaking on pillow.Upon switching to new line, noted crack in tubing where blood was leaking from.Product issue with cracking causing blood to back up into tubing, inaccurate blood pressure, switched to new stat-lock with no issues.It was reported this occurred with two devices.One device was used on a patient and one was not used on a patient.This report addresses the device that was used on a patient.
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