Catalog Number 8881135609 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/23/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is unknown; awareness date has been used for this field.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 bd alaris¿ pca module set empty monoject¿ syringe barrel iv set assembly foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter.Reported issue per customer: excess unknown solution was observed around the ribcage and above the rubber stopper of the syringe barrel.Customer has 5 full cases and 1 partial case that has 11 packs of 10 each which equals the 860 each.
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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 foreign matter could not be verified due to the product not being returned for failure investigation.A device history record review for model 8881135609 lot number 2213015864 was performed by the supplier.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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 while using bd alaris¿ pca module set empty monoject¿ syringe barrel iv set assembly foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: reported issue per customer: excess unknown solution was observed around the ribcage and above the rubber stopper of the syringe barrel.Customer has 5 full cases and 1 partial case that has 11 packs of 10 each which equals the 860 each.
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Search Alerts/Recalls
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