|
Model Number 66024008 |
Device Problem
Contamination (1120)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/22/2022 |
Event Type
malfunction
|
Event Description
|
During set-up/inspection of treatment, when a iv3000 1 hand 10x12cm pouch was opened, it was confirmed there was a dust-like foreign substance in it.Treatment was completed, without any delay, with a backup.No injury or other complications were reported.
|
|
Manufacturer Narrative
|
The device was not returned for analysis.No photographs were provided in support of this complaint.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.It was reported during set-up/inspection of treatment, when a iv3000 1 hand 10x12cm pouch was opened, it was confirmed there was a dust-like foreign substance in it.Probable cause is that the dust is too small and too light in color, the equipment cannot be detected and rejected.The batch records were reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review revealed a similar instances in the last three years.A review of prior escalation actions found no actions applicable to the scope of this case.A risk management review concluded that without further information the alleged failure mode can not be directly linked to a specific failure mode within the risk file although it does contain several failure modes that can result in contamination, of which have a worst case risk rating of medium risk level and is still adequate.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.
|
|
Search Alerts/Recalls
|
|
|