C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number N/A |
Device Problem
Activation Problem (4042)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2023 |
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 returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
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Event Description
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It was reported by customer that multiple lots affected, product is failing, safety is not engaging during deployment.Additional information received 11/17/2023: it was reported there was no visible or obvious damage present.Issues occurred once deployed to the patient.It was reported this occurred with two devices.This report addresses the first device.
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Search Alerts/Recalls
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