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Catalog Number 2C2063K |
Device Problem
Material Split, Cut or Torn (4008)
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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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The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that there was a cut in the administration tubing of a large volume infusor.This issue was further described as, ¿tubing snapped into half which straightening the tubing¿.This issue was discovered during preparation.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H4: the lot was manufactured between january 03, 2022- january 05, 2022 h10: the device was received for evaluation.Visual inspection was performed and a cut was observed on a segment of the tubing line.A functional testing was performed which revealed a leak at the cut area of the tubing line.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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