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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL PILLING AORTIC PUNCH STD TIP 5.0
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TELEFLEX MEDICAL PILLING AORTIC PUNCH STD TIP 5.0 Back to Search Results
Catalog Number 353450
Device Problems Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906)
Patient Problems Tissue Damage (2104); Excessive Tear Production (2235)
Event Date 03/01/2014
Event Type  Injury  
Event Description
Complaint alleges: the aortic punch got stuck while using it on either a vein or an artery.It damaged the vessel but the physician was able to complete the procedure without a negative outcome.The doctor sutured the damaged vessel.Patient's current condition reported as fine.
 
Manufacturer Narrative
Device not received by manufacturer in time for this report.
 
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Brand Name
PILLING AORTIC PUNCH STD TIP 5.0
Type of Device
AORTIC PUNCH
Manufacturer (Section D)
TELEFLEX MEDICAL
nuevo laredo
MX 
Manufacturer Contact
elaine burkle, rn
p.o. box 12600
durham, NC 27709
9194334957
MDR Report Key3804550
MDR Text Key4527252
Report Number3004365956-2014-00185
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number353450
Device Lot Number02A1301684
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/12/2014
Initial Date FDA Received04/28/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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