BECTON, DICKINSON & CO. (SPARKS) BD PREPSTAIN¿; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
|
Back to Search Results |
|
Model Number 490100 |
Device Problem
Structural Problem (2506)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/27/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported that while using the bd prepstain¿ that there was a lid issue.It has been confirmed with the engineer that before the replacement, the customer held the lid with his hands to avoid falling, so the lid did not fall off.Tripath us ii - centrifuge pneumatic support rod aging.
|
|
Manufacturer Narrative
|
H.6 investigation summary: complaint reports lid failure on centrifuge associated with prepstain (catalog number 490100) serial number (b)(6).Complaint alleges centrifuge hydraulic rod failure, no support for the lid to stay open.Customer advised no one was hurt or injured.Service replaced the hydraulic rods and post intervention the centrifuge is operating normally.Root cause attributed to faulty hydraulic rods.This complaint is a confirmed failure of the instrument based on the service investigation.Dhr review is not required because the part that allegedly failed is not tested as part of the manufacturing process but is shipped separately and tested during installation.Review of risk management files confirms there are no new or modified risks associated with this failure mode.There are no corrective action plans or other corrections occurring.Bd quality will continue to monitor for trends associated with failure of "centrifuge." h3 other text : see h.10.
|
|
Event Description
|
It was reported that while using the bd prepstain¿ that there was a lid issue.It has been confirmed with the engineer that before the replacement, the customer held the lid with his hands to avoid falling, so the lid did not fall off.Tripath us ii - centrifuge pneumatic support rod aging.
|
|
Search Alerts/Recalls
|
|
|