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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION/BD ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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CAREFUSION/BD ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number A9UX2XXX
Device Problem Disconnection (1171)
Patient Problems Awareness during Anaesthesia (1707); Hypoventilation (1916)
Event Date 02/27/2017
Event Type  Injury  
Manufacturer Narrative
No physical sample was provided for evaluation. The customer provided a photograph of the reported issue. However, a physical sample is needed to determine the root cause. 2-years of complaints were reviewed and no trend was detected for this issue. At this time we are unable to determine a root cause since the physical sample was not provided. Despite this, our current manufacturing process and quality process was reviewed and no issues were found regarding the reported issue.
 
Manufacturer Narrative
It has been confirmed by carefusion/bd that the complaint sample is not available for evaluation. Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding the situation reported with the device. If a sample or any additional information becomes available a follow up emdr will be submitted. (b)(4).
 
Event Description
The customer reported that "the circuit leak was very large and i had to physically hold the system tightly together while waiting for the replacement, during which time ventilation and inhalational anesthetic administration was compromised. ".
 
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Brand NameANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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
mindy faber
75 north fairway drive
vernon hills, IL 60061
MDR Report Key6443304
MDR Text Key110217410
Report Number8030673-2017-00308
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberA9UX2XXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2017
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 Initial

Patient Treatment Data
Date Received: 03/29/2017 Patient Sequence Number: 1
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