SMITHS MEDICAL ASD, INC. MEDEX EXTENSION SETS MULTI LINE WITH STOPCOCK; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number MX6812 |
Device Problems
Fluid/Blood Leak (1250); Obstruction of Flow (2423); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Device lot number are unknown, no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
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Event Description
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It was reported that there was an emergency in the operating room, and blood could not pump through the extension tubing.They experienced leaking and were hard to connect to the insertion port.There has been no report of observable clinical symptoms or a change in symptoms, or adverse affects identified in the patient.
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Manufacturer Narrative
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Other, other text: h6.Health impact, and evaluation codes: updated.No product was returned therefore device analysis could not be performed.A device history record (dhr) review could not be completed as the lot number was unknown.No action was taken and if the product is returned, the complaint will be re-opened for further investigation.
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Search Alerts/Recalls
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