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 12/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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).Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using an unspecified bd alaris pump iv set the tubing bulged.There was no report of patient impact.The following information was provided by the initial reporter: made a general comment of seeing bulging in the pumping segment of alaris pump iv sets, the sets were not saved.
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Event Description
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It was reported while using an unspecified bd alaris pump iv set the tubing bulged.There was no report of patient impact.The following information was provided by the initial reporter: made a general comment of seeing bulging in the pumping segment of alaris pump iv sets, the sets were not saved.
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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 pumping segment of alaris pump iv sets had bulging in it.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.H3 other text : see h10.
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Search Alerts/Recalls
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