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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
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TELEFLEX MEDICAL PU DP-40K DISP PUNCH 4.0MM Back to Search Results
Catalog Number DP-40K
Device Problems Failure to Eject (4010); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/26/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The facility has communicated that the device is not available for investigation.No issues or discrepancies were found in the device history record of product code dp-40k / batch 74m1701017 that can be related to the failure mode reported in the customer complaint.Corrective actions cannot be established, the customer complaint cannot be confirmed, and the root cause cannot be determined since it is necessary to receive the physical sample to perform a proper investigation and to confirm the alleged defect.If the alleged defective samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the punch did not make a hole in the aorta and did not want to come out of the place.Hard force and pulling to left and right was used to remove the device.The same issue occurred on the second use.There was no patient injury.
 
Manufacturer Narrative
(b)(4).Sample was received without its original packing instead the sample was sent on a ziploc bag with a disinfection tag.Also, dried blood was spotted at the core and at the blade of the aortic punch.Qty.Received: 1 ea.Qty.Mfg.: 1,080 ea.Sample was tested manually , and it works fine.Core returns without obstructions.Sample was tested as it is received from the customer by performing cuts to a pork aorta to review the functionality of the unit.No issues were found during testing.As additional test, the sample was disassembled in order to be cleaned.The punch was assembled back again with the same components in order to perform cuts to a pork aorta to review the functionality of the unit.No issues were found during testing.It is not possible to establish a corrective action since the sample works properly.The root cause for the condition reported could not be identified.Customer complaint cannot be confirmed, since the sample was found within functional specifications.Sample was tested as received and works properly.No other issues were found during testing.However, the personnel of the assembly line were notified on (b)(6) 2018 for awareness).
 
Event Description
It was reported that the punch did not make a hole in the aorta and did not want to come out of the place.Hard force and pulling to left and right was used to remove the device.The same issue occurred on the second use.There was no patient injury.
 
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Brand Name
PU DP-40K DISP PUNCH 4.0MM
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 Key7699460
MDR Text Key114721556
Report Number3004365956-2018-00213
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/27/2018
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 Date11/11/2022
Device Catalogue NumberDP-40K
Device Lot Number74M1701017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/27/2018
Initial Date FDA Received07/18/2018
Supplement Dates Manufacturer Received08/10/2018
Supplement Dates FDA Received08/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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