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Catalog Number 2C4063K |
Device Problems
Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter last name: (b)(6).E1: initial reporter facility name: (b)(6).E1: initial reporter city: (b)(6).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 a large volume folfusor leaked.This was observed when unpacking the transportation box.During further inspection, the flow restrictor came loose (separated).The device contained cloxacillin.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 from june 19, 2023 to june 21, 2023.H10: the actual device was received for evaluation.A visual inspection was performed which noted fluid inside the bag which suggested a leak may have occurred.Further inspection revealed the cause of leak inside the sealed green bag was due to broken tubing at the solvent-bonded junction of the flow restrictor.The reported condition was verified.The cause of the condition was determined to be a manufacturing related issue.The morphology of the end of broken tubing and internal sites of breakage suggested there was extra solvent present which caused melting of the tubing.The melting likely decreased the integrity of the tubing, causing breakage to occur.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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