Catalog Number 391350 |
Device Problems
Bent (1059); Material Twisted/Bent (2981)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 04/13/2017 |
Event Type
Injury
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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.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that the catheter of a bd neoflon¿ iv cannula system 24 g x 1 in.Bent and twisted while being inserted.There was no harm to the patient but the incident resulted in a needle stick to the medical professional.It was also reported that no medical intervention was necessary/provided.
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Manufacturer Narrative
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Results: two used and 48 unused samples were returned for evaluation.A visual inspection of the used samples revealed catheter peelback.Ten of the 48 unused samples were tested for bevel angle and tip outside diameter measurements.The samples met the bevel angel and tip od specifications.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6230410.A manufacturing review observed no abnormalities that could have influenced the reported issue.Conclusion: the root cause for this incident was determined to be material used to manufacture the device.Remedial action required: capa (b)(4) has been initiated to review the iv catheter tubing material.
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Search Alerts/Recalls
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