Catalog Number 383323 |
Device Problem
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 12/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical 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 when using the bd saf-t-intima¿ iv catheter safety system, the device experienced foreign matter within the fluid path.This event occurred 15 times.The following information was provided by the initial reporter.The customer stated: an orthopedic nurse's examination prior to use revealed a foreign body on the indwelling needle catheter tube.
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Manufacturer Narrative
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Medical 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 when using the bd saf-t-intima¿ iv catheter safety system, the device experienced foreign matter within the fluid path.This event occurred 15 times.The following information was provided by the initial reporter.The customer stated: an orthopedic nurse's examination prior to use revealed a foreign body on the indwelling needle catheter tube.
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Manufacturer Narrative
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H6: investigation summary bd was unable to perform a thorough investigation as no sample, or batch number were provided.A device history review could not be completed as no batch number was provided.
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Event Description
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It was reported when using the bd saf-t-intima¿ iv catheter safety system, the device experienced foreign matter within the fluid path.This event occurred 15 times.The following information was provided by the initial reporter.The customer stated: an orthopedic nurse's examination prior to use revealed a foreign body on the indwelling needle catheter tube.
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Search Alerts/Recalls
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