Catalog Number 51449 |
Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/13/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This report is being filed to provide additional information.Investigation: a dhr search was not performed for this complaint record as the reported adverse event did not relate to activities associated with the manufacturing of this lot.All lots must meet acceptance criteria for release.Correction: terumo bct customer support contacted the distributor on (b)(6) 2019 to alert them of this error.Root cause: based on the clinical findings, the use of the expired set was caused by an operator error.
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Event Description
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The customer did not provide any patient information or outcome.
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Manufacturer Narrative
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Investigation is in process.A follow-up report will be provided.
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Event Description
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Upon review of the information provided by the distributor, it was discovered that an expired gdp-10 graft delivery system disposable was used on a patient.The gdp-10 disposable was labeled with an expiration date of 09-01-2019 and the procedure was performed on (b)(6) 2019.The product was collected and processed then injected back to the patient.Patient information and outcome are not available at this time.The gdp-10 graft delivery system set is not available for return because it was discarded by the customer.
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Search Alerts/Recalls
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