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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION/BD 2K8032 CARDIOPULMONARY RESUSCITATION AID KIT

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CAREFUSION/BD 2K8032 CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Catalog Number 2K8032
Device Problem Failure to Disconnect (2541)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2017
Event Type  Injury  
Manufacturer Narrative
Unfortunately the device sample was not available for further investigation. At this time the unable to disconnect failure mode cannot be confirmed. However based on similar complaints as a probable root cause it is considered that the current mirror finish surface on the elbow makes the mask very difficult to remove. The new textured surface finish on the elbow allows the mask to be easily removed as indented. A corrective and preventative action has also been opened to further investigate into this known failure mode.
 
Manufacturer Narrative
Customer advocacy has reached out to customer to provide sample for the investigation. (b)(6) label was provided to the customer. At this time we are currently waiting for the sample. Once the investigation is complete or if we receive any additional information we will provide a follow up emdr. (b)(4).
 
Event Description
The customer reported that "during resuscitation and post intubation mask does not come off bag elbow during and after use". Customer reported no patient injury.
 
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Brand Name2K8032
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
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 Key6490835
MDR Text Key113290404
Report Number8030673-2017-00320
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8032
Device Lot Number0001015634
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number8030673-4/27/17-002-R

Patient Treatment Data
Date Received: 04/13/2017 Patient Sequence Number: 1
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