Model Number 101/810/080 |
Device Problems
Break (1069); Material Separation (1562)
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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 a patient had two (2) cannulas delivered, and both were found to be faulty (broken) at opening and unable to be used.No patient injury or clinical affects was reported and the outcome was reported as resolved.(b)(4) and (b)(4) represent the same patient.
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Manufacturer Narrative
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Other text: b3: date of event is unknown; no information has been provided to date.D3, g1,2 email is: (b)(4).Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Manufacturer Narrative
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Evaluation codes: updated.Email is: (b)(6).No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.
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Search Alerts/Recalls
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