SMITHS MEDICAL ASD, INC. SAF-T HOLDER MULTI SAMPLE LUER ADAPTER W/ BLOOD; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COL
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Catalog Number 96000 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the product was defective.No patient injury was reported.
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Manufacturer Narrative
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This is a supplied item and the device history record (dhr) is at the supplier.No further information has been made available to date.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.(unique identifier-udi) and operator of device are unknown.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Search Alerts/Recalls
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