Catalog Number YKAD7001 |
Device Problems
Delivered as Unsterile Product (1421); Problem with Sterilization (1596)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition unknown.
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Event Description
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It was reported that tears (hole) on the blue wrap caused the kit to become de-sterile.Patient was woken up.
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Manufacturer Narrative
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The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidence were provided for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.Also, kits do not have dhr¿s.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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It was reported that tears (hole) on the blue wrap caused the kit to become de-sterile.Patient was woken up.
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Manufacturer Narrative
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Please note the following corrections: d3 (manufacturer entity) and g1 (manufacturing site).
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Event Description
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It was reported that tears (hole) on the blue wrap caused the kit to become de-sterile.Patient was woken up.
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Search Alerts/Recalls
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