Catalog Number UNKNOWN |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in 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 the unspecified bd infusion set ballooned in the pump with excessive pressure.The following information was provided by the initial reporter: upon inspection, it was discovered that the tubing had ballooned in the pump with excessive pressure.
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Event Description
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It was reported that the unspecified bd infusion set ballooned in the pump with excessive pressure.The following information was provided by the initial reporter: upon inspection, it was discovered that the tubing had ballooned in the pump with excessive pressure.
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Manufacturer Narrative
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H6: investigation summary: no product or photo was returned by the customer.It was reported by the customer that the tubing had ballooned in the pump with excessive pressure, and then the tubing was replaced and primed with tpn, and the pump immediately began alarming "occlusion".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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Search Alerts/Recalls
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