Catalog Number 107140 |
Device Problem
Material Puncture/Hole (1504)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported a hole on the return line of a prismaflex hf1000 set was observed.There was ¿presence of blood¿ in the set (no further details).It was not specified when in the process this occurred.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
The device was received for evaluation.Visual inspection of the set showed all the luer connectors conform.The blood was clotted and a rinsing accessory was added on the pbp line that was not the original accessory of the set.Visual inspection also showed a hole on the return line.The reported condition was verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|