C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number N/A |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Chemical Exposure (2570)
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Event Date 09/18/2023 |
Event Type
malfunction
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Event Description
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It was reported by customer that during assessment, patient stated he had chemo leaking yesterday and his pump "stopped" overnight while he was sleeping.Dry, white drainage also noted around patient's right nipple area and on port needle infusion set.Cadd pump stopped and disconnected at 1416.When attempting to flush port, unable to do so as resistance was met.Port needle noted to be inserted at an angle.Patient's port was de-accessed and re-accessed.Port was able to be flushed with saline.Blood return noted.Port needle removed and band-aid left in place.Additional info from customer: ((b)(6) 2023) this even involved a hazardous drug spill around the area and on the patient.The catheter break was discovered by leaking.When the catheter broke there was leaking but no piece broken off.
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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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Search Alerts/Recalls
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