Model Number 367364 |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/31/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 a retraction issue - delay or no retraction.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: "the needle retraction not going well, we have difficulty pressing and we cannot afford to "tinker" when the needle is still in place.".
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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 a retraction issue - delay or no retraction.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: "the needle retraction not going well, we have difficulty pressing and we cannot afford to "tinker" when the needle is still in place.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2023-01-03.H.6.Investigation summary: bd received 4 samples from the customer in support of this complaint.The 4 returned samples along with 10 retained samples from the bd inventory were taken, and the push button was pressed to retract the needle and all needles retracted as expected.Bd was unable to duplicate or confirm the customer¿s indicated failure mode from the returned and retained sample test results.No root cause could be established for the reported defect.The device history records were reviewed with no issues being identified.There were no related quality notifications.All processes and final inspections comply with specification requirements h3 other text : see h.10.
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Search Alerts/Recalls
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