Catalog Number UNKNOWN |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the unspecified bd 20 g cathena catheter experienced difficult safety mechanism disengagement.The following information was provided by the initial reporter: both nurses had a similar adverse event that they did not declare: when the mandrin was removed, the safety device (white box) remained on the base and released the mandrin (risk of major exposure to blood).Dr wanted to make a declaration but the device and the packaging were thrown away before he could do so he remembered that it was a kt 20g the nurse did not remember the reference.Two cardiology nurses each placed a peripheral venous catheter (bd cathena).Afterwards, they wanted to take a blood sample but no blood was returned.However, when she connected the infusion set, the infusion went through.Confirm if there were any consequences for the patient or medical staff? -yes, there were consequences.For the patient: he had to go through another sampling for a blood test.For the nurse: loss of time and additional handling.
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Event Description
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It was reported that the unspecified bd 20 g cathena catheter experienced difficult safety mechanism disengagement.The following information was provided by the initial reporter: both nurses had a similar adverse event that they did not declare: when the mandrin was removed, the safety device (white box) remained on the base and released the mandrin (risk of major exposure to blood).Dr wanted to make a declaration but the device and the packaging were thrown away before he could do so he remembered that it was a kt 20g the nurse did not remember the reference.Two cardiology nurses each placed a peripheral venous catheter (bd cathena).Afterwards, they wanted to take a blood sample but no blood was returned.However, when she connected the infusion set, the infusion went through.- confirm if there were any consequences for the patient or medical staff? -yes, there were consequences.For the patient: he had to go through another sampling for a blood test.For the nurse: loss of time and additional handling.
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Manufacturer Narrative
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H6: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.H3 other text : see h10.
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Search Alerts/Recalls
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