Catalog Number JC7751 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 the spike of a y-type blood/soln set disconnected from the tubing.This issue was identified during preparation.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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B3: the reporter informed that the device disconnected while the nurse was priming with a gentle tug to ensure it would not detach during the procedure.H10: the device was received for evaluation.A visual inspection was done which observed that the spike came apart from the tubing.The other components were observed correctly placed and according to specification.The insertion level of the affected code was inspected and the level met specification.The reported condition was verified.The cause of the condition was due to a human assembly issue during the manufacturing process.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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H6: investigation findings was changed from c1601 to c13, and investigation conclusions was changed from d0301 to d15.H10: the cause of the condition was changed from human assembly issue during the manufacturing process to undetermined.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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