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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES AORTIC PERFUSION CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

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EDWARDS LIFESCIENCES AORTIC PERFUSION CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number DCT24A
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 01/28/2014
Event Type  No Answer Provided  
Event Description
It was reported by warehouse in (b)(4) that on the aortic perfusion cannula "hair contamination was found inside the package during incoming inspection." this was found during (b)(4) incoming inspection and never had contact with the patient/hospital.
 
Manufacturer Narrative
The device evaluation is currently in process into root cause.
 
Manufacturer Narrative
It was reported by warehouse in (b)(4) that "hair contamination was found inside the package during incoming inspection." evaluation: it was found that the particulate was embedded in the product and was found to meet edwards specifications.This complaint is considered cosmetic in nature.Trends for this issue are in control and will continue to be monitored.Manufacturing records were reviewed and there were no related ncr's found.There will be no pra or capa initiated at this time.The instructions for use, training and risk control measures are appropriate at this time.Trends will continue to be monitored on through the edwards quality system.
 
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Brand Name
AORTIC PERFUSION CANNULA
Type of Device
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
EDWARDS LIFESCIENCES
12050 lone peak parkway
draper UT 84020
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
12050 lone peak parkway
draper UT 84020
Manufacturer Contact
walt wiegand
12050 lone peak parkway
draper, UT 84020
8015655200
MDR Report Key3630515
MDR Text Key4202936
Report Number3008500478-2014-00025
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K123370
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Invalid Data
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/28/2014,01/28/2014
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
Device Expiration Date10/01/2016
Device Model NumberDCT24A
Device Lot Number59618939
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/28/2014
Device Age3 MO
Date Report to Manufacturer02/28/2014
Initial Date Manufacturer Received 01/28/2014
Initial Date FDA Received02/17/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/23/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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