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Model Number 491453 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that while using the bd totalys multiprocessor consumables kit, 480 that there were missing labels.The following information was provided by the initial reporter: this is a report about a labeling issue.According to the customer¿s information, a centrifuge tube without a label was found before usage.
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Event Description
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It was reported that while using the bd totalys multiprocessor consumables kit, 480 that there were missing labels.The following information was provided by the initial reporter: this is a report about a labeling issue.According to the customer¿s information, a centrifuge tube without a label was found before usage.
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Manufacturer Narrative
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The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes.D9: returned to manufacturer on: 2023-02-21.H.6.Investigation summary: the customer complained about a centrifuge tube from an unknown lot number of catalog 491453 missing a 2d barcode label.Material 500024399 is a purchased subcomponent that is used in catalog 491453.The customer communicated that the lot number of 500024399 that was missing the 2d barcode was supplier lot number 20u1321.A dhr review of 491453 could not be performed because a lot number was not provided.However, material 500024399 is a purchased subcomponent that is used in catalog 491453.The centrifuge tubes are polypropylene plastic injection molded parts purchased from an approved bd supplier.The supplier applies a 2-dimensional barcode on the tubes that is used to support automated chain of custody for the specimen.When received into the bd mebane, nc facility they are subjected to incoming qc inspection using an ansi, single sampling, level i, at an aql of 1.0%.A review of the inspection documentation identified that 500024399 lot 20u1321 was received and inspected on two occasions without any issues identified.A retain analysis could not be conducted because retain samples of this product are not kept by bd.Two pictures were provided by the customer.One of the pictures contains a picture of one tube without the label and the 2nd picture is a picture of the bag label.The unlabeled tube and bag label were also returned to the mebane, nc location.The complaint is confirmed.Bd apologizes for the inconvenience caused by the issue.
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Search Alerts/Recalls
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