Catalog Number UNKNOWN |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
Infiltration into Tissue (1931)
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Event Date 03/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical 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.
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Event Description
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It was reported that the needle pierced through the unspecified bd nexiva¿ diffusics¿ closed iv catheter system during use.The following information was provided by the initial reporter: "it was reported that needle went through the catheter".
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Manufacturer Narrative
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H6: investigation summary our quality engineer inspected the one photo submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the photo.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review could not be performed because a lot number was not provided.
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Event Description
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It was reported that the needle pierced through the unspecified bd nexiva¿ diffusics¿ closed iv catheter system during use.The following information was provided by the initial reporter: "it was reported that needle went through the catheter".
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Search Alerts/Recalls
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