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Model Number 72200830 |
Device Problem
Corroded (1131)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: case-(b)(4).
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Event Description
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It was reported that when the inner chambers of the cannulas were being sterilized, it was found that they were discolored, with black margins/scratches and corroded/damaged at the tap aperture.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found that three cannulas were returned.There was no discoloring at the tap aperture.A scope was used to look down into the cannula and found debris in the cannula inner tube.There was no discoloration around the rotation ring.An analysis of the customer provided images revealed small dark streaks along the inside of the cannulas.It seemed the material buildup pictured was located at the rotation ring of the device.The provided product identification information did not match any known release of this part and thus a manufacturing record review could not be conducted.The complaint was confirmed.Factors that may have contributed to the reported event include improper flush valve use, use of detergents above 11 ph, or improper sterilization techniques.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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