Model Number 383313 |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd saf-t-intima¿ iv catheter safety system experienced a damaged catheter tip.The following information was provided by the initial reporter: ¿ what was the failure that the product presented? spare burr on needle silicone.¿ which component had the deviation? needle ¿ was there any impact on the patient/health worker? (detail) no ¿ was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc)? (detail) no.
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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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Manufacturer Narrative
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H6: investigation summary since no photos or samples displaying the reported condition of catheter tip integrity 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.
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Event Description
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It was reported that the bd saf-t-intima¿ iv catheter safety system experienced a damaged catheter tip.The following information was provided by the initial reporter: ¿ what was the failure that the product presented? spare burr on needle silicone.¿ which component had the deviation? needle ¿ was there any impact on the patient/health worker? (detail) no ¿ was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc)? (detail) no.
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Search Alerts/Recalls
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