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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION/BD RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS CARDIOPULMONARY RESUSCITATION AID KIT

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CAREFUSION/BD RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Catalog Number 2K8032
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2017
Event Type  Injury  
Manufacturer Narrative
One opened sample was received for further evaluation. During the visual inspection it was observed that the tubing was disassembled from the resuscitator. Solvent remnant was observed between the pvc tubing and the treaded housing. It is considered that an insufficient amount of solvent between these components could provoke this type of disconnection. Therefore the reported failure mode has been confirmed. After a thorough investigation of the manufacturing procedure it is considered that the root cause of the disconnection reported is related to the assembly personnel not following procedure during solvent application. Personnel have been retrained on the solvent application procedure to prevent insufficient application in the future.
 
Manufacturer Narrative
Customer advocacy has reached out to customer to provide sample for the investigation. Ups 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 the tubing detaches from the o2 inlet during bagging. Reported item was being used on patient. No patient harm or medical intervention required. The customer reported via email "that the patient did not have a low oxygen saturation, the device was replaced immediately upon noticing the issue and the procedure was completed with another device".
 
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Brand NameRESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS
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 Key6533005
MDR Text Key110217120
Report Number8030673-2017-00330
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
PMA/PMN Number
EN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8032
Device Lot Number0000911374
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2017
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

Patient Treatment Data
Date Received: 04/29/2017 Patient Sequence Number: 1
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