Catalog Number 10013364T |
Device Problem
Defective Component (2292)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/08/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
|
|
Event Description
|
It was reported that bd alaris smartsite texium secondary set was damaged the following information was received by the initial reporter with the following verbatim: \tubing disconnected just under the drip chamber when chemotherapy was removed from biological safety cabinet, exposing user to hazardous product.Model #: 10013364t.
|
|
Manufacturer Narrative
|
No product or photo was returned by the customer.The customer complaint of drip chamber tubing separation could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 10013364t because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
|
|
Event Description
|
No additional information was provided.
|
|
Search Alerts/Recalls
|