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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-40K DISP PUNCH 4.0MM; INSTURMENTS,SURGICAL,CARDIOVASCULAR
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TELEFLEX MEDICAL PU DP-40K DISP PUNCH 4.0MM; INSTURMENTS,SURGICAL,CARDIOVASCULAR Back to Search Results
Catalog Number DP-40K
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device review history could not be conducted since the lot number was not provided.The device sample has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.
 
Event Description
Alleged event: the punch got stuck in the aorta and would not release.The surgeon had to make a bigger hole in the aorta to get the device out and repair the site.The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4).Visual inspection was performed.One piece from product code dp-40k was received as part of this complaint.The piece looks used and remains of blood and tissue are on tip of product.The piece was received stuck and it is not able to operate due to the condition mentioned.Dimensional tests according to qa-pun-001/f2 & f3 were performed and acceptable results in core and blade parts were obtained.Functional test could not be performed due the sample condition that was received.No corrective actions can be established since the dimensional test demonstrated that the core and blade are according to specification and according to ifu 151894mx a product should be cleaned before additional openings are created, but based on the sample received the complete cut area contains remains of blood and tissue.Therefore, the complaint cannot be confirmed, and a root cause cannot be determined at this time.
 
Event Description
Alleged event: the punch got stuck in the aorta and would not release.The surgeon had to make a bigger hole in the aorta to get the device out and repair the site.The patient's condition was reported as fine.
 
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Brand Name
PU DP-40K DISP PUNCH 4.0MM
Type of Device
INSTURMENTS,SURGICAL,CARDIOVASCULAR
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX   88275
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key5396540
MDR Text Key37017283
Report Number3004365956-2016-00096
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2016
Device Operator Health Professional
Device Catalogue NumberDP-40K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/19/2016
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 N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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