Catalog Number JC7751 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/23/2023 |
Event Type
malfunction
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Event Description
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It was reported that a y-type blood/solution set had a malformed spike.This event was further described as, ¿one of the spikes seems to have extra plastic blocking the passage¿.This was observed during priming.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the device was received for evaluation.Visual inspection was performed and the spike was observed damaged.The reported condition was verified.The cause of the condition was a supplier assembly issue during manufacturing.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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Manufacturer Narrative
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H11: correcting the following fields to align with the product reported in d4: d4: model #, d4: expiration date, d4: unique identifier (udi) #, g4: combination product.The d4: unique device identifier (udi) # is for the product reported in d4.This product code is sold/distributed outside the us, but is deemed same as or similar to product distributed in the us.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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