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Catalog Number MMC2071B |
Device Problem
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 06/22/2022 |
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 an administration set separated.The event occurred while disconnecting the set from the fluid warmer cartridge, the luer separated from the tubing.Furthermore, the line was connected to a fluid warmer cartridge then connected to the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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H4: device manufacture date: january 2022.H10: the actual device was not available; however, a photograph of the sample and a retained sample were evaluated.The returned photograph was reviewed, and it was noted that the tubing was detached from the luer connector.The retention sample was visually inspected and did not identify any abnormalities that could have contributed to the reported condition.Functional testing including gravity tested was performed and no leak was observed.The reported condition was verified for the photographic sample.The cause of the condition could not be determined.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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H4: device manufacture date: january 2022.H10: the actual device was not available; however, a photograph of the sample and a retained sample were evaluated.The returned photograph was reviewed, and it was noted that the tubing was detached from the luer connector.The retention sample was visually inspected and did not identify any abnormalities that could have contributed to the reported condition.Functional testing including gravity tested was performed and no leak was observed.The reported condition was verified for the photographic sample.The cause of the condition could not be determined.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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