Model 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 09/14/2021 |
Event Type
malfunction
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Event Description
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It was reported that foreign matter was found on the tip of the bd saf-t-intima¿ iv catheter safety system needle.The following information was provided by the initial reporter, translated from chinese: "on (b)(6) 2021, the patient underwent indwelling needle puncture.When the indwelling needle was opened for examination, foreign matter was found at the tip of the needle, and the indwelling needle was replaced.".
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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 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.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 that foreign matter was found on the tip of the bd saf-t-intima¿ iv catheter safety system needle.The following information was provided by the initial reporter, translated from chinese: on (b)(6) 2021, (b)(6).
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Manufacturer Narrative
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H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received. the lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
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Search Alerts/Recalls
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