Catalog Number 8065752134 |
Device Problem
Kinked (1339)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/07/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).
|
|
Event Description
|
A customer reported kinked tubing noted during an eye surgery.The product was replaced and the procedure was completed without harm to the patient.A product sample was requested for evaluation.
|
|
Manufacturer Narrative
|
A device history record of the reported lot shows that the order was built to specification.A sample has not been returned for this complaint; therefore, visual inspection and functional testing could not be performed.The root cause of the customer's complaint could not be established as a sample has not been received.Without a sample, it is not possible to isolate the root cause.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|