Catalog Number UNKNOWN |
Device Problem
Inaccurate Delivery (2339)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/28/2021 |
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 unspecified bd¿ infusion set had flow issues and over-infused during use.The following information was provided by the initial reporter: "if suspected overinfusion, pause pump and power down-keep all tubing sets in place.".
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Event Description
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It was reported that the unspecified bd¿ infusion set had flow issues and over-infused during use.The following information was provided by the initial reporter: "if suspected overinfusion, pause pump and power down-keep all tubing sets in place.".
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Manufacturer Narrative
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H.6.Investigation: no product or photo was returned by the customer.The customer complaint that the suspect over-infused could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model and lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.
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Search Alerts/Recalls
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