Catalog Number 8065752918 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
|
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 nurse reported that the purple infusion sleeves are too big.The procedure was completed with the product without harm to the patient.No further details were available.A product sample was received at the manufacturing site and it is awaiting evaluation.
|
|
Manufacturer Narrative
|
The lot specific to this event is not known; therefore, lot history and device history record reviews are not possible.Two purple infusion sleeves were returned for this complaint.The samples were visually inspected and no abnormalities were observed.The texture on the inner wall of the shafts and tips of the infusion sleeves was intact.The inner diameter of both sleeves was found to be within specification.The irrigation flow rate was performed using a lab stock cassette, tip and hand piece.No drop presented from the hand piece after the irrigation was off for 5 seconds.The root cause of the customer's complaint could not be established as the returned infusion sleeves met specifications.After a thorough investigation of this complaint, it has been determined that the samples met specifications; therefore, no action will be taken at this time.Quality assurance will continue to monitor customer complaints via the complaint review meetings and will take action for any future occurrences as is deemed necessary.(b)(4).
|
|
Event Description
|
A customer reported feels that the purple infusion sleeves are too big.The procedure was completed with the product without harm to the patient.No further details were available.A product sample was received at the manufacturing site and it is awaiting evaluation.
|
|
Search Alerts/Recalls
|