Catalog Number 383007 |
Device Problem
Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/05/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
|
|
Event Description
|
It was reported that the intima-ii 20gax1.16in prn slm adapter had a molding defect on it.The following information was provided by the initial reporter, translated from chinese to english: "connection part between the hub and the prn was not flat".
|
|
Manufacturer Narrative
|
H6: investigation summary unfortunately a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.Additionally the photograph submitted by the facility has been reviewed by our team of quality engineers.Based on the provided image they have determined that the most likely root cause for this event is related to a misalignment of the luer and adapter during the automated installation of the prn.H3 other text : see h10.
|
|
Event Description
|
It was reported that the intima-ii 20gax1.16in prn slm adapter had a molding defect on it.The following information was provided by the initial reporter, translated from chinese to english: "connection part between the hub and the prn was not flat.".
|
|
Search Alerts/Recalls
|