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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER
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MAQUET CARDIOPULMONARY AG AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER Back to Search Results
Device Problem Burst Container or Vessel (1074)
Patient Problem No Information (3190)
Event Date 12/18/2013
Event Type  malfunction  
Event Description
It was reported that the catheter ruptured on insertion.Additional details have been requested but have not been provided by the customer.Ref: (b)(4).
 
Manufacturer Narrative
The device has been requested for return.A supplemental medwatch will be submitted if additional info becomes available.
 
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Brand Name
AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER
Type of Device
CATHETER
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
restatt
GM 
Manufacturer (Section G)
MAQUET CARDIOPULMONARY AG
kehler strabe 31
restatt 7643 7
GM   76437
Manufacturer Contact
janice pevide
45 barbour pond dr
wayne, NJ 07470
9737097753
MDR Report Key3784616
MDR Text Key4379971
Report Number8010762-2014-00023
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/16/2014,12/15/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date12/18/2013
Event Location Hospital
Date Report to Manufacturer01/10/2014
Initial Date Manufacturer Received 12/18/2013
Initial Date FDA Received01/16/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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