Catalog Number 307875 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Exposure to Body Fluids (1745)
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Event Date 07/03/2019 |
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.Initial reporter phone#: (b)(6).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 that during use of the syringe 10ml w/snd curitba it leaked blood through the inner rubber and drained by the plunger, causing the professional to contact the patient's blood and the need to collect again (they stop "having the necessary pressure for aspiration).Foreign complaint the following information was provided by the initial reporter, translated from portuguese to english: a lot of syringes, in the moment of blood collection, are leaking through the stopper and drained by the plunger, causing the professional to have contact with the patient's blood and the need to collect again (the syringes has no pressure to do the aspiration).
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Manufacturer Narrative
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H.6.Investigation: batch history analysis was performed, quality notifications and maintenance records were verified where no records potentially related to failure were found.Photos were made available by the client for evaluation, but without the samples it was not possible to conduct a thorough investigation of the incident.Based on the photo analysis it is not possible to reproduce and identify the root cause for the reported incident.Production processes are validated against the defined acceptance criteria.It is not possible to confirm the complaint.H3 other text : see h.10.
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Event Description
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It was reported that during use of the syringe 10ml w/snd curitba it leaked blood through the inner rubber and drained by the plunger, causing the professional to contact the patient's blood and the need to collect again (they stop "having the necessary pressure for aspiration).Foreign complaint the following information was provided by the initial reporter, translated from portuguese to english: a lot of syringes, in the moment of blood collection, are leaking through the stopper and drained by the plunger, causing the professional to have contact with the patient's blood and the need to collect again (the syringes has no pressure to do the aspiration).
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Search Alerts/Recalls
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