CAREFUSION/BD INFANT FLOW LP NASAL PRONGS,EXTRA SMALL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
|
Back to Search Results |
|
Catalog Number 777000XS |
Device Problem
Occlusion Within Device (1423)
|
Patient Problem
Low Oxygen Saturation (2477)
|
Event Date 11/20/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
The customer reported that the ¿prong was sealed, and the patient didn't get any air.Patient desaturated, they responded by switching to a mask.There was no harm to the patient.It was reported that ¿there was nothing wrong with product production.The prong was sealed with silicone for testing purposes by the customer himself.Apparently the customer used it accidentally on a patient¿.The product was not in a sealed package.
|
|
Manufacturer Narrative
|
Follow up submission: the sample was not returned for evaluation.However, the customer has confirmed that the device was manipulated by the customer to use as a testing device.The customer stated that the device was put in use on a patient by a mistake.Based on the investigation, we have determined that this is related to customer misuse.The customer has been sent a notification with preventative steps to ensure that a device this is no longer safe for patient use be properly marked and not in the patient care environment.
|
|
Search Alerts/Recalls
|
|
|