MAUDE Adverse Event Report: CAREFUSION/BD INFANT FLOW LP NASAL PRONGS,EXTRA SMALL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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.

• Brand Name: INFANT FLOW LP NASAL PRONGS,EXTRA SMALL
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): CAREFUSION/BD; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): CAREFUSION/BD; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6210331
• MDR Text Key: 63426694
• Report Number: 2021710-2016-05111
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 777000XS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other