Catalog Number 383403 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Thrombus (2101)
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Event Date 01/21/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).A sample is available for evaluation.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 on (b)(6) 2016, a bd intima-ii closed iv catheter system was inserted into a patient for infusion therapy after surgery.The iv remained in the patient until (b)(64) 2016, at which time a new iv was placed.On (b)(6) 2016, the patient complained of pain at the iv insertion site so a nurse used a steel cannula for the patient's infusions instead.On (b)(6)2016, the patient claimed that the vein in his hand had become hard.There was no obvious swelling but a thrombus was identified by a color doppler ultrasound.The nurse applied topical magnesium sulfate and alcohol to the patient's iv insertion site to help relieve pain.The patient also received "chinese traditional medicine" via iv infusion to dissolve the thrombus.The patient recovered on (b)(6) 2016.
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Manufacturer Narrative
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Correction: the initial mdr reported this incident as both an adverse event and product problem.A correction is being submitted to report the incident as an adverse event only.
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Manufacturer Narrative
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Results: although it was initially reported that a sample would be available for evaluation, a sample was not returned.A review of the device history record and the device sterility record revealed no irregularities during the manufacture of the reported lot # 5229059.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.A sample was not returned for evaluation.
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Search Alerts/Recalls
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