Catalog Number 383318 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cellulitis (1768)
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Event Date 11/21/2022 |
Event Type
Injury
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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.
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Event Description
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It was reported that after fluid infusion with bd saf-t-intima¿ closed iv catheter system, cellulitis formed and patient was treated with antibiotic treatment.The following information was provided by the initial reporter: cellulitis formation after fluid infusion with the product.According to the stuff, the patient treated with antibiotic treatment.
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Manufacturer Narrative
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H6: investigation summary: since no photos or samples displaying the reported condition of irritation / inflammation were available for examination, we were unable to fully investigate this incident.Dhr was reviewed and no qns or other events were found related to the complaint stated by the customer.According to sampling plan applied for product performance, this lot was accepted.H3 other text : see h10.
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Event Description
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It was reported that after fluid infusion with bd saf-t-intima¿ closed iv catheter system, cellulitis formed and patient was treated with antibiotic treatment.The following information was provided by the initial reporter: cellulitis formation after fluid infusion with the product.According to the stuff, the patient treated with antibiotic treatment.
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Search Alerts/Recalls
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