BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® URINE COLLECTION CUP; SPECIMEN TRANSPORT AND STORAGE CONTAINER
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Catalog Number 364941 |
Device Problems
Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2022 |
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.Investigation summary: bd had not received samples or photos for evaluation.Bd does not retain samples of this product therefore, this investigation is limited.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure modes of incorrect labeling/difficult to operate.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported when using the bd vacutainer® urine collection cup, the device experienced the inability to aspirate from the tube, and missing label information.This event occurred once.The following information was provided by the initial reporter.The customer stated: when opening the box, several jars without a label (lid label).When the nurse wants to aspirate the urine with the urinary tube, with some jars it is less easy or even necessary to take it twice.
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Search Alerts/Recalls
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