Catalog Number JC8723 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/20/2022 |
Event Type
malfunction
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Event Description
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It was reported that a large hole was discovered in the tubing of a clearlink system y-type blood/solution set.The issue was identified during setup and preparation.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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D4: expiration date: 12/26.H10: the device was received for evaluation.Visual inspection observed a hole in the tubing.The device failed pressure testing and clear passage testing.The reported condition was verified.The cause of the condition was due to incorrect placement of the set in the pouch during manufacturing, leaving part of the set outside the pouch and exposed to the packaging machine¿s blades.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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