Model Number 367364 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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There were multiple medical device types reported to be involved.The information for each 510(k) number is as follows: common device name: intravascular administration set.Medical device type: fpa.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® ultratouch¿ push button blood collection set there was molding defect sharp protrusions.The following information was provided by the initial reporter.The customer stated: "the one-side wing was found to be partially deformed.".
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Manufacturer Narrative
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The following fields have been updated with additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-09-15.H.6.Investigation summary: bd did receive one sample and 4 photographs from the customer in support of this complaint.Evaluation of the returned sample and photographs provided shows evidence of the indicated issue damaged wing.Additionally, 10 retained samples from the bd inventory were visually inspected and no defects were found.Bd was able to confirm the customer¿s indicated failure mode with the returned sample and photographs provided, however retained samples were satisfactory.Bd was not able to identify a root cause for the indicated failure mode.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.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 when using the bd vacutainer® ultratouch¿ push button blood collection set there was molding defect sharp protrusions.The following information was provided by the initial reporter.The customer stated: "the one-side wing was found to be partially deformed.".
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Search Alerts/Recalls
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