Catalog Number 405198 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd epilor¿ plastic lor syringe foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that the syringe had drops of what appears to be some liquid inside the syringe.Drops of what appears to be some liquid inside the syringe.
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Manufacturer Narrative
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H.6.Investigation: our quality engineer inspected the 5 photos submitted for evaluation.The reported issue of foreign matter was not confirmed upon inspection of the photos.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review was not performed since a lot number was not provided.H3 other text : see h.10.
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Event Description
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It was reported while using bd epilor¿ plastic lor syringe foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that the syringe had drops of what appears to be some liquid inside the syringe.Drops of what appears to be some liquid inside the syringe.
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Search Alerts/Recalls
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