Catalog Number 391492 |
Device Problems
Break (1069); Device Dislodged or Dislocated (2923)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 07/22/2015 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturing location for this product is (b)(4).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed in the report.Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.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 venflon iv cannula 20 g x 1 in.Was inserted into the left upper arm of a test patient who was participating in a (b)(6) study at the clinical facility of( b)(6) limited.The cannula was inserted at 6:32 am on (b)(6) 2015 to collect blood samples for pharmacokinetic analysis of study drug.It was removed at 1:45 am on (b)(6) 2015 due to a blockage.Immediately after the removal, it was observed that the cannula was not intact and the tip of it was missing and the patient complained of pain at the site.The patient was transferred to a hospital where he received a ct scan of his left elbow and the broken catheter tip was found in his subcutaneous tissue.An exploration/foreign body removal surgery was done under local anesthesia on (b)(6) 2015.The patient's post-operative stay was uneventful and he was discharged from the hospital on (b)(6) 2015.
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Manufacturer Narrative
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Results: a sample is not available for evaluation.A visual inspection of 200 retention samples for lot # 14l2441m revealed that all samples were in good condition.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 14l2441m.A manufacturing review revealed no issues related to equipment performance during the manufacture of this device.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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