Qn#(b)(4).A device history record review was performed on the epidural needle with no relevant findings.Visual inspection could not be performed as no sample was returned by the customer for investigation.The customer did however, provide a photo that shows a bent epidural needle (b)(4).A corrective action is not required at this time.Although, the customer provided a photo that illustrates a bent needle, a potential root cause could not be determined based on the information provided and without a sample.The reported complaint of a bent needle was confirmed based on a photo provided by the customer.However, complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural needle with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the needle bending during use could not be determined based upon the information provided and without a sample.
|