Catalog Number 2C2009K |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/20/2023 |
Event Type
malfunction
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Event Description
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It was reported that the tube of a large volume infusor was broken.The issue occurred in the pharmacy before patient use.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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H4: the lot was manufactured from august 31, 2022 to september 1, 2022.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the actual device was returned for evaluation.A visual inspection via the naked eye noted a damaged segment on the tubing.Indentation marks from the manufacturing flow wrap sealer equipment were observed on the damaged area of the tube set.The reported condition was verified.The cause of the condition was determined to be related to the manufacturing process.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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