Catalog Number 405609 |
Device Problem
Device Markings/Labelling Problem (2911)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/29/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Medical device expiration date: unknown.The customer's address is unknown.Unknown, (b)(6), 00000 usa has been used as a default.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
|
|
Event Description
|
It was reported that the tray spn qnke22g3.5 l/b-d/e label did not state that it contained bupivacaine, while another tray label did.The missing information was noticed before use.The following information was provided by the initial reporter: "health professional stated that she has two of the same 405609 tray (was not provided lot # but said it could be obtained) and one label stated it contains bupivacaine while the other did not say this.".
|
|
Manufacturer Narrative
|
Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.A device history review could not be completed as no batch number was provided.
|
|
Event Description
|
It was reported that the tray spn qnke22g3.5 l/b-d/e label did not state that it contained bupivacaine, while another tray label did.The missing information was noticed before use.The following information was provided by the initial reporter: "health professional stated that she has two of the same 405609 tray (was not provided lot # but said it could be obtained) and one label stated it contains bupivacaine while the other did not say this.".
|
|
Search Alerts/Recalls
|