Catalog Number UNKNOWN |
Device Problem
Inaccurate Flow Rate (1249)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: 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.(b)(4).
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Event Description
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It was reported that the unspecified bd infusion set bag was empty about 4 hours later.The following information was provided by the initial reporter: new bag was started at 11/19 @ 1717, then found bag empty about 4 hours later.The rate going 2.99 ml/hr should fall more than that time.
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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 there was a faulty tubing 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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Event Description
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It was reported that the unspecified bd infusion set bag was empty about 4 hours later.The following information was provided by the initial reporter: new bag was started at 11/19 @ 1717, then found bag empty about 4 hours later.The rate going 2.99 ml/hr should fall more than that time.
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Search Alerts/Recalls
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