Catalog Number ASKU |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Initial reporter address: (b)(6).Initial reporter phone no.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that an unspecified quantity of unknown access sets were dirty; further described as "looks like hair sometimes." it was not specified when in the process step this occurred.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
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
|