Catalog Number 326638 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.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 prior to using the bd ultra-fine¿ ii 3/10ml insulin syringe the stoppers were found to be slanted.The following information was provided by the initial reporter, translated from japanese to english: it was reported that some pusher tip rubbers are slanted.
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Manufacturer Narrative
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The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 23-jan-2024.H6: investigation summary: samples were received and an investigation was performed.This is the 4th complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.
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Event Description
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It was reported that prior to using the bd ultra-fine¿ ii 3/10ml insulin syringe the stoppers were found to be slanted.The following information was provided by the initial reporter, translated from japanese to english: it was reported that some pusher tip rubbers are slanted.
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Search Alerts/Recalls
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