Catalog Number UNKNOWN |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2022 |
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 in and the (b)(4) fda registration number has been used for the manufacture report number.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 experienced overinfusion.The following information was provided by the initial reporter: we are having a surge of unexplainable issues with our pumps and disposable and i feel uncomfortable with them at this point.Pca pump was found with empty syringe.Pca new syringe hung at 2145 on previous shift, patient ordered to receive max of 2mg/hr.Pump information shows 16mg delivered overnight (1:1 concentration) leaving 14mg or 14mls missing.Of note, tubing had loose knot between pca syringe and y site attachment to primary line.
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Event Description
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It was reported that the unspecified bd infusion set experienced overinfusion.The following information was provided by the initial reporter: we are having a surge of unexplainable issues with our pumps and disposable and i feel uncomfortable with them at this point.Pca pump was found with empty syringe.Pca new syringe hung at 2145 on previous shift, patient ordered to receive max of 2mg/hr.Pump information shows 16mg delivered overnight (1:1 concentration) leaving 14mg or 14mls missing.Of note, tubing had loose knot between pca syringe and y site attachment to 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 of air in line could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot and model number 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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Search Alerts/Recalls
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