Catalog Number 2C8537 |
Device Problems
Disconnection (1171); Component Missing (2306)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
This event occurred during the unspecified date of (b)(6) 2020.(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that the end of a clearlink system continu-flo solution set had broken off.This issue was further described as, the last centimeter of plastic was broken off (the portion that would fit into the intravenous port).It was also reported that the broken piece was not present.The broken set was discovered during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.
|
|
Manufacturer Narrative
|
H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|