Catalog Number 367977 |
Device Problems
Inability to Auto-Fill (1044); Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.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 bd vacutainer® sst¿ blood collection tubes that there was underfill or low draw and tube push off.This occurred 22 times.The following information was provided by the initial reporter:
customer is reporting product 367977 lot no.2306642 unable to draw or stay on the needle.
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Manufacturer Narrative
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Investigation summary: no customer photos or customer samples were received for review and analysis.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Retain testing cannot be completed due to batch# 2306642 being expired.(product was used by the customer prior to the expiration date).Bd makes no claims on expired product.Bd is unable to confirm the customers reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.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 that while using bd vacutainer® sst¿ blood collection tubes that there was underfill or low draw and tube push off.This occurred 22 times.The following information was provided by the initial reporter: customer is reporting product 367977 lot no.2306642 unable to draw or stay on the needle.
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Search Alerts/Recalls
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