Catalog Number H7498060100121 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/11/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device from the reported event has been returned to angiodynamics, however the device evaluation has not yet been concluded.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
|
|
Event Description
|
As reported by angiodynamics' distributor in (b)(4), " it was reported that there was air leaking into the manifold when withdrawing fluid into the syringe.There was no reported patient injury." the used device has been returned to angiodynamics for evaluation.
|
|
Manufacturer Narrative
|
A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the perceptor dts and manifolds product family and the failure mode "device air bubbles." no adverse trend was indicated.As received, the 3v manifold was returned with what appeared to be bio material {blood} inside and out.A visual inspection upon receipt was performed.It was noted during the visual inspection that the o-ring was missing from the rotating adaptor.The reported complaint description was confirmed for rotating adaptor (ra) leaking air.The root cause of the air leak was a result of a missing o-ring in the rotating adaptor assembly on the manifold.The root cause of this issue is operator error during the manual assembly process.This device non-conformance was not observed during the 100% visual inspection of the ra/o-ring post assembly.A department wide re-training for manufacturing associates who work in the manual manifold assembly area has been performed on the ra swaging procedure and visual inspections per angiodynamics' procedures.(pr20066).
|
|
Search Alerts/Recalls
|