Catalog Number 326631 |
Device Problem
Missing Information (4053)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the bd ultra-fine¿ insulin syringe had no scale markings on it.The following information was provided by the initial reporter, translated from japanese: "the user reported that the print on the barrel was missing.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 26-apr-2023.H6: investigation summary: the customer returned (1) 0.3ml 29ga syringe, reporting scale marking missing.The syringe was visually examined and observed missing scale markings on the barrel.Upon visual examination, embecta was able to confirm the customer-indicated failure.Due to the batch being unknown, no dhr review can be completed.
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Event Description
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It was reported that the bd ultra-fine¿ insulin syringe had no scale markings on it.The following information was provided by the initial reporter, translated from japanese: "the user reported that the print on the barrel was missing.".
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Search Alerts/Recalls
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