Catalog Number 385158 |
Device Problem
Failure to Deliver (2338)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/21/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
It was reported while using bd q-syte¿ microbore tri-extension there were flow issues and blockages.There was no report of patient impact.The following information was provided by the initial reporter: bd q-syte small bore tri ext.2 lumen blocked.In icu bd q-syte tri ext.Is getting used, and septum is closed.
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 01-feb-2023.H6.Investigation summary: our quality engineer inspected the 1 tri-extension set returned with 4 q-syte samples, one was a standalone, and 1 photo submitted for evaluation.The reported issue of flow issues - fluid blockage was confirmed upon inspection of the samples.Analysis of the samples showed that 1 of the q-sytes samples did not have the proper slit opening.Bd determined that the cause of the failure was associated to the manufacturing process.During the manufacturing process the septums of the q-sytes have a slit cut into them via a blade.If the blade is dull, broken, or missing in the manufacturing machinery than the slit will not be properly cut into the septum resulting in the reported defect.Production records were reviewed, and this batch met our manufacturing specification requirements.
|
|
Event Description
|
It was reported while using bd q-syte¿ microbore tri-extension there were flow issues and blockages.There was no report of patient impact.The following information was provided by the initial reporter: bd q-syte small bore tri ext.2 lumen blocked.In icu bd q-syte tri ext.Is getting used, and septum is closed.
|
|
Search Alerts/Recalls
|