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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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 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 3 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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The following fields were updated due to additional information: d9: device available for evalution?: yes.D9: returned to manufacturer on: 2022-10-12 h.6.Investigation summary: bd received 3 samples and 4 photos from the customer in support of this complaint.The customer samples and photos were evaluated, and the issue of cut tubing was observed.Additionally, 30 retain samples were subjected to a visual test for cut tubing.All of the samples passed exhibiting no cuts or damage to the tubing.Bd is able to confirm the customer¿s reported failure modes of cut tubing based on the customer samples and photo analysis; however, the issue was not observed in the retain testing.The 3 customer samples and photos, along with 100 retention samples from the bd inventory, were subjected to visual testing for preactivation and there was no issue observed relating to preactivation as all the samples passed testing exhibiting an iv needle that had not yet been activated.Bd is unable to confirm the customer¿s reported failure mode of preactivation based on the customer photo, sample and retain analysis.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.
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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 3 times.The following information was provided by the initial reporter.The customer stated: the customer reported about cut tubing.
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Search Alerts/Recalls
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