|
Model Number 21-7230-24 |
Device Problem
Material Twisted/Bent (2981)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/12/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.A review of the manufacturing process for the product was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Operator of the device: patient/consumer.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).
|
|
Event Description
|
It was reported that upon replacing the cannula to change the insertion site, the patient noticed it was bent.No patient injury was reported.
|
|
Search Alerts/Recalls
|
|
|