Catalog Number 309653 |
Device Problem
Fungus in Device Environment (2316)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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Material no.309653, batch no.Unknown.It was reported that before use of the bd¿ syringe w/ bd luer-lok¿ tip there was mold found on the syringe.The following information was provided by the initial reporter: foreign substance: mold on item.
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Manufacturer Narrative
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H.6.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history review could not be completed as no batch number was provided.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.H3 other text : see section h.10.
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Event Description
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Material no.309653; batch no.Unknown.It was reported that before use of the bd¿ syringe w/ bd luer-lok¿ tip there was mold found on the syringe.The following information was provided by the initial reporter: foreign substance: mold on item.
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Search Alerts/Recalls
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