Catalog Number 381411 |
Device Problem
Defective Component (2292)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/06/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The initial reporter also notified the fda via medwatch #mw5082558.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 with the use of the bd insyte-n autoguard shielded iv catheter there was an issue with catheter tip was not intact after placement.
|
|
Event Description
|
It was reported with the use of the bd insyte-n¿ autoguard¿ shielded iv catheter there was an issue with catheter tip was not intact after placement.
|
|
Manufacturer Narrative
|
Investigation summary: dhr review was performed on lot number: 8206774; the lot number was built on afa line 4 from 30jul18 through 01aug18 packaged on packaging line 11 from 31jul18 through 01aug18 for the total quantity of (b)(4) units.Review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the pir.Observations and testing could not be performed because units were not received for investigation of this incident.Indeterminate ¿ without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.
|
|
Search Alerts/Recalls
|