Catalog Number 7N8378 |
Device Problems
Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address: (b)(6).Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the tubing of a one-link non-dehp standard bore catheter extension set split open and leaked.It was further reported that the distal end of tubing bulged and split open when power injector was flushing with saline.The device had been in use for five (5) minutes when the issue occurred.There was no direct contact or exposure and no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Additional information was added to h4 and h6.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction: b4/f8: date of this report in mdr follow up #2 is being corrected from blank to 06/24/2021.
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Search Alerts/Recalls
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