Catalog Number UNKNOWN |
Device Problem
Failure to Infuse (2340)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2021 |
Event Type
malfunction
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Event Description
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It was reported that 1 unspecified bd smart site¿ infusion set had flow issues.The following information was provided by the initial reporter : it was reported by the customer that the secondary fluids are not infusing.
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Manufacturer Narrative
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Date of event: unknown.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.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.Medical device manufacture date : unknown.
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Manufacturer Narrative
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Date of event: unknown.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.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.Medical device manufacture date: unknown.
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Event Description
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It was reported that 1 unspecified bd smart site¿ infusion set had flow issues.The following information was provided by the initial reporter: it was reported by the customer that the secondary fluids are not infusing.
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Manufacturer Narrative
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Investigation summary: no product or photo was returned by the customer.It was reported that the secondary fluids are not infusing.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because model and lot numbers are unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
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Event Description
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It was reported that 1 unspecified bd smart site¿ infusion set had flow issues.The following information was provided by the initial reporter : it was reported by the customer that the secondary fluids are not infusing.
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Search Alerts/Recalls
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