Model Number 367338 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/23/2022 |
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.Investigation summary: bd received 2 photographs from the customer in support of this complaint.An evaluation of the photographs was performed and provided confirms reported defect of needle retraction.Additionally, 5 retention samples from the bd inventory were taken, and the push button was pressed to retract the needle.All needles retracted as expected.Bd was able confirm the customer¿s indicated failure mode based on the photographs provided, however retained samples were satisfactory.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 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 there was a retraction issue - delay.The following information was provided by the initial reporter.The customer stated: "the needle did not retract properly when the button was pressed.The problem did not occur on any other device.".
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Event Description
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It was reported when using the bd vacutainer® push button blood collection set there was a retraction issue - delay.The following information was provided by the initial reporter.The customer stated: "the needle did not retract properly when the button was pressed.The problem did not occur on any other device.".
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Manufacturer Narrative
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The following fields have been updated with additional information: d.9 device available for eval? yes.Returned to manufacturer on - 08/02/2022.H.6.Investigation summary: bd received 1 sample and 2 photographs from the customer in support of this complaint.An evaluation of the sample and photos was performed and the issue of retraction failure was observed, additionally, 5 retention samples from the bd inventory were taken, and the push button was pressed to retract the needle.All needles retracted as expected.Bd was able confirm the customer¿s indicated failure mode based on the evaluation of the sample and the photographs provided, however retained samples were satisfactory.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 process and final inspections comply with specification requirements.
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Search Alerts/Recalls
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