Catalog Number 367324 |
Device Problems
Material Puncture/Hole (1504); Failure to Obtain Sample (2533)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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There were multiple device types reported to be involved.The information for the additional device types are as follows.Medical device type: jka / fpa.Common device name: blood specimen collection device; intravascular administration set 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 when using the bd vacutainer® push button blood collection set, the device experienced failure of product to contain blood.This event occurred once.The following information was provided by the initial reporter.The customer stated: customer problem: customer states collection device has hole in tubing.
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples, but 1 photos were provided for investigation.The photos were reviewed and the indicated failure mode for hole in tubing with the incident lot was not observed.Additionally, 50 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to hole in tubing as all samples met specifications.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 mode hole in tubing.Bd was not able to identify a root cause for the indicated failure mode.
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Event Description
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It was reported when using the bd vacutainer® push button blood collection set, the device experienced failure of product to contain blood.This event occurred once.The following information was provided by the initial reporter.The customer stated: customer problem: customer states collection device has hole in tubing.
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Search Alerts/Recalls
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