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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-48K DISP PUNCH 4.8MM; INSTRUMENTS, SURGICAL, CARDIOV

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TELEFLEX MEDICAL PU DP-48K DISP PUNCH 4.8MM; INSTRUMENTS, SURGICAL, CARDIOV Back to Search Results
Catalog Number DP-48K
Device Problems Failure to Cut (2587); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/26/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history record of batch number provided has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.The facility has communicated that the device is not available for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the punch was not cutting the aorta completely.They backed the item out and tried to use it again and on the 2nd attempt it would not open; guess tissue was stuck in it.They were able to use scissors to complete the procedure.There was no patient harm and the patient is doing fine.
 
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Brand Name
PU DP-48K DISP PUNCH 4.8MM
Type of Device
INSTRUMENTS, SURGICAL, CARDIOV
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX   88275
Manufacturer Contact
effie jefferson
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key7282526
MDR Text Key100660011
Report Number3004365956-2018-00046
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
Report Date 01/26/2018
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 Date05/26/2022
Device Catalogue NumberDP-48K
Device Lot Number74F1702736
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2018
Initial Date FDA Received02/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2017
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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