Catalog Number ABC1206 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone no.(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 the sterile packaging of the unspecified quantity of solution sets were damaged.This was observed prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Initial reporter phone no.(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 the sterile packaging of the unspecified quantity of solution sets were damaged.This was observed prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Additional information was added to d9, h3, h4, h6 and h10.H10: the device was received for evaluation.Visual inspection was performed and showed damaged primary packaging.Functional tests were not performed since failure is easily identifiable through visual inspection.The reported condition was verified.The cause of the condition was due to human production 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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Search Alerts/Recalls
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