Model Number 367326 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/16/2022 |
Event Type
malfunction
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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 cut tubing.This event occurred 6 times.The following information was provided by the initial reporter.The customer stated: the customer reported about cut tubing.
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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 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 cut tubing.This event occurred 6 times.The following information was provided by the initial reporter.The customer stated: the customer reported about cut tubing.
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Manufacturer Narrative
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H.6.Investigation summary: bd received 9 samples and 12 photos for investigation.The photos were reviewed and the customer¿s indicated failure modes of damaged (cut) tubing and preactivation was observed.Additionally, the customer samples and were evaluated by visual examination and the indicated failure modes of damaged (cut) tubing and preactivation with the incident lot was observed.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 has been confirmed for the indicated failure modes damaged (cut) tubing and preactivation.Bd determined that the root cause of the indicated failure mode of cut tubing was attributed to the manufacturing process.Bd was not able to identify a root cause for the indicated failure mode of preactivation.H3 other text : see h.10.
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Search Alerts/Recalls
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