Model Number 382533 |
Device Problems
Defective Device (2588); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/20/2022 |
Event Type
malfunction
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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.Initial reporter phone# : (b)(6).Initial reporter fax# : (b)(6).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 1 bd insyte¿ autoguard¿ bc shielded iv catheter had blood control valve issues.The following information was provided by the initial reporter : the user facility reported that many of the 20gauge ivs are not working properly in the er.The blood control technology does not stop the blood flow after the angiocath is placed.
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Event Description
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It was reported that 1 bd insyte¿ autoguard¿ bc shielded iv catheter had blood control valve issues.The following information was provided by the initial reporter : the user facility reported that many of the 20gauge ivs are not working properly in the er.The blood control technology does not stop the blood flow after the angiocath is placed.
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Manufacturer Narrative
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H6: investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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Search Alerts/Recalls
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