Catalog Number 394901 |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that connecta plus3 blue blend cap was missing.The following information was provided by the initial reporter: this is a report about a missing cap of connecta.According to the customer's report, it was confirmed that there was no cap on the male luer component.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 8/2/2021.H.6.Investigation: bd received a sample and photos submitted for evaluation.The reported issue was confirmed upon inspection of the sample and photos.Bd determined the root cause of the issue to be human error during the manual filling step of the product;s packaging.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.
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Event Description
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It was reported that connecta plus3 blue blend cap was missing.The following information was provided by the initial reporter: this is a report about a missing cap of connecta.According to the customer's report, it was confirmed that there was no cap on the male luer component.
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Search Alerts/Recalls
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