Catalog Number UNKNOWN |
Device Problem
Free or Unrestricted Flow (2945)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that while using the unspecified bd administration set the secondary backflowed into the primary.The following information was provided by the initial reporter: secondary medication (minibag) started running rapidly, and was reported to infuse into primary line.
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Manufacturer Narrative
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Medical device expiration date: unknown a sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown 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) the franklin lakes fda registration number has been used for the manufacture report number.
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Event Description
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It was reported that while using the unspecified bd administration set the secondary backflowed into the primary.The following information was provided by the initial reporter: secondary medication (minibag) started running rapidly, and was reported to infuse into primary line.
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Manufacturer Narrative
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H6: investigation summary no product or photo was returned by the customer.The customer complaint that the secondary medication started running rapidly and was reported to infuse into the primary 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.
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Search Alerts/Recalls
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