Catalog Number 328506 |
Device Problems
Detachment Of Device Component (1104); Sticking (1597)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: n/a.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 a bd ¿ insulin syringe 31g x 8 mm was found during use where the needle had separated from the hub and became stuck in the insulin vile.There was no report of injury or medical intervention needed.
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Manufacturer Narrative
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Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
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Search Alerts/Recalls
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