Catalog Number 381323 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation summary: samples have been received but have not been evaluated.A review of the device history and manufacturing records revealed no irregularities during the manufacture of the reported lot # 7049178.Conclusion: a conclusion is not yet available.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 the catheter of the bd insyte-w¿ peripheral venous catheter, was loose.This resulted in a puncture failure.There was no report of injury or medical intervention.
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Manufacturer Narrative
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Results: bd received four (4) actual samples in opened packaging were returned for investigation.A review of the device history record revealed no irregularities during the manufacture of the reported lot number.The outer diameter (od) of the hubs were measured and the od was found within specification.The inner diameter (id) of the needle covers were measured and the id were found within specification.No abnormalities were observed on the samples 2, 3 and 4.The outer diameter (od) of the hubs and the inner diameter (id) of the needle covers were found within specification.Conclusion: no abnormalities were observed on the samples 2, 3 and 4.The loose catheter adapter could have been caused by the cannula hub deformity found in sample the cannula hub was produced by supplier.
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Search Alerts/Recalls
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