Catalog Number UNKNOWN |
Device Problems
Break (1069); Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
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Event Description
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It was reported that the unspecified bd introsyte introducer experienced 2 cases of the sheath not splitting as intended and 1 case of device damage/deformation while still considered operable.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via introsyte introducer survey that the clinician experienced introducer breakage / defective or damaged introducer, introducer was difficult to thread, splittable sheath did not completely separate / introducer did not peel apart correctly, introducer difficult to remove from vein and plastic tip of introducer seemed to stick / adhere to the catheter.
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Manufacturer Narrative
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H6: investigation summary bd was unable to perform a thorough investigation as no material number, sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.H3 other text : see h.10.
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Event Description
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It was reported that the unspecified bd introsyte introducer experienced 2 cases of teh sheath not splitting as intended and 1 case of device damage/deformation while still considered operable.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported via introsyte introducer survey that the clinician experienced introducer breakage / defective or damaged introducer, introducer was difficult to thread, splittable sheath did not completely separate / introducer did not peel apart correctly, introducer difficult to remove from vein and plastic tip of introducer seemed to stick / adhere to the catheter.
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Search Alerts/Recalls
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