Catalog Number 383712 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Blood Loss (2597)
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Event Date 03/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd pegasus¿ safety closed iv catheter system prn was loose.This was discovered during use.The following information was provided by the initial reporter: the patient had effusion in the chest but had less coughing at night.The nurse sealing the tube, and found that the prn was loosen from adapter and missing after 45 minutes.Because the pp connector was connected with infusion pump, the clamp was not sealed, which caused blood leakage on patient and the blood wet two clothes.Lost prn not found on site.The nurse uses a syringe to connect the prn when sealing the tube, and holds the cap by hand to seal the tube.
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Manufacturer Narrative
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H.6 investigation summary : no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.
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Event Description
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It was reported that bd pegasus¿ safety closed iv catheter system prn was loose.This was discovered during use.The following information was provided by the initial reporter: the patient had effusion in the chest but had less coughing at night.The nurse sealing the tube, and found that the prn was loosen from adapter and missing after 45 minutes.Because the pp connector was connected with infusion pump, the clamp was not sealed, which caused blood leakage on patient and the blood wet two clothes.Lost prn not found on site.The nurse uses a syringe to connect the prn when sealing the tube, and holds the cap by hand to seal the tube.
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Search Alerts/Recalls
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