Model Number 367342 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2022 |
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.Date of event: unknown.The date received by manufacturer has been used for this field.
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Event Description
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It was reported when using the bd vacutainer® push button blood collection set the customer states that needles are difficult to puncture through the caps.The following information was provided by the initial reporter.The customer stated: "it was reported by the customer that these needles are difficult to puncture through the caps.".
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Manufacturer Narrative
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H.6.Investigation summary: bd did not receive customer samples or photos from the customer in support of this complaint.Therefore, 30 retention samples from the bd inventory were subjected to visual inspection and functional testing and there were no issues related to needle point integrity as all retain samples passed testing.Therefore, this complaint cannot be confirmed based on retain sample testing results.Bd is unable to confirm the customer¿s reported failure mode of difficult to perform function based on retain sample testing analysis.The device history record was 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 customer states that needles are difficult to puncture through the caps.The following information was provided by the initial reporter.The customer stated: "it was reported by the customer that these needles are difficult to puncture through the caps.".
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Search Alerts/Recalls
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