Catalog Number 515573-ZAT |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
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Event Description
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It was reported that ten bd prm/n35/std/50cm experienced air in the syringe/tube.The customer reported, "when connecting with terumo chemo safe infusion set, air got mixed and occlusion occurred frequently.".
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Manufacturer Narrative
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Per additional information, this incident is no longer considered reportable.Air bubbles within the device are not considered likely to affect the operation of the device or cause serious injury to the user.
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Event Description
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It was reported that ten bd prm/n35/std/50cm experienced air in the syringe/tube.The customer reported, "when connecting with terumo chemo safe infusion set, air got mixed and occlusion occurred frequently.".
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Search Alerts/Recalls
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