Catalog Number 383083 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/12/2022 |
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 that the bd intima-ii¿ closed iv catheter system leaked fluid from the connection site during use.The following information was provided by the initial reporter, translated from (b)(6): "after thyroid surgery, the patient needed to use a closed venous indwelling needle for intravenous infusion on (b)(6) 2022.After the infusion set was connected with the indwelling needle, fluid leakage was found at the interface of the heparin cap during exhaust, which affected the use and was replaced.".
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Event Description
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It was reported that the bd intima-ii¿ closed iv catheter system leaked fluid from the connection site during use.The following information was provided by the initial reporter, translated from chinese: "after thyroid surgery, the patient needed to use a closed venous indwelling needle for intravenous infusion on (b)(6) 2022.After the infusion set was connected with the indwelling needle, fluid leakage was found at the interface of the heparin cap during exhaust, which affected the use and was replaced.".
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Manufacturer Narrative
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H6: investigation summary 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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