BECTON DICKINSON IND. CIRURGICAS LTDA BD¿ BLUNT FILL NEEDLE; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
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Catalog Number 305243 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2023 |
Event Type
malfunction
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Event Description
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It was reported that the bd¿ blunt fill needle experienced foreign matter, contaminated.The following information was provided by the initial reporter, translated from portuguese to english: the material disposable needle 25x12 blunt tip ref.(b)(4), where it was identified that the item had a layer of white paint (plastic) on the rod and barrel.
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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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Manufacturer Narrative
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H6: investigation summary a batch history (dhr) analysis was performed, quality notifications were checked and no records potentially related to this defect were found for the lot and sub-lots consumed (assembled needle).It is possible to confirm the incident because the customer sent the photos, this is a process originating incident.Photos received by our quality team for investigation.Upon visual evaluation, white foreign matter is observed on the hub.The foreign substance is identified as epoxy, an adhesive used to join the cannula with the hub.This condition is part of the assembly process and when it occurs, the length of the injectable area is verified.Based on the teams investigation, possible root cause is associated with failure of the vision system.Adjustment made to the physical position of the clog camera and detection tool.
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Event Description
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It was reported that the bd¿ blunt fill needle experienced foreign matter, contaminated.The following information was provided by the initial reporter, translated from portuguese to english: the material disposable needle 25x12 blunt tip ref.(305243), where it was identified that the item had a layer of white paint (plastic) on the rod and barrel.
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