Model Number 4447006-02 |
Device Problem
Fail-Safe Problem (2936)
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Patient Problems
Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
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Event Type
malfunction
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Manufacturer Narrative
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This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
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Event Description
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As reported by user facility: upon de-accessing a patient's port, sure can safety did not engage and clinician obtained a needle stick injury.Clinician and the source patient were both tested for hepatitis b and c and hiv.Current status of clinician is healthy.
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Manufacturer Narrative
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This report has been identified as b.Braun inc.Internal report number (b)(4).One used device was received for evaluation.The safety mechanism was tested, and it could be activated without any difficulties.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.A batch record review for the reported lot number did not reveal any abnormalities or non-conformances of this nature.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The returned device met requirements according to specification, and the reported failure could not be reproduced.If additional pertinent information becomes available a follow-up report will be filed.
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Event Description
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As reported by user facility: upon de-accessing a patient's port, surecan safety did not engage and clinician obtained a needle stick injury.Clinician and the source patient were both tested for (b)(6).Current status of the clinician is healthy.
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Search Alerts/Recalls
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