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U.S. Department of Health and Human Services

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

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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.
 
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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 Key6210331
MDR Text Key63426694
Report Number2021710-2016-05111
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number777000XS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/29/2016
Initial Date FDA Received12/28/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/08/2017
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 Number1
Patient Outcome(s) Other;
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