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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-44K DISP PUNCH 4.4MM

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TELEFLEX MEDICAL PU DP-44K DISP PUNCH 4.4MM Back to Search Results
Catalog Number DP-44K
Device Problem Failure to Cut (2587)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual inspection of the product involved in the complaint could not be conducted since the sample was not provided.An attempt to inspect current stock of material was made but at the time there is no inventory of the involved product code available at the facility nor is being manufactured at the time.The device history record of the product dp-44k batch number 74h1701864 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No nonconformance reports were originated for the lot in question that can be associated to the complaint reported.All materials used during the assembly met current specifications.Dhr shows that the product was assembled and inspected according to our specifications.No conclusion can be established at this time based on the lack of defective of sample.It is necessary the physical sample to perform a properly investigation.The customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause.If the sample becomes available this investigation will be updated with the evaluation results.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that while the doctor tried to use the aortic punch, the device did not work properly.The cut was not clean, and it did not finish the cut, so they had to use scissors to clean and finish the hole.
 
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Brand Name
PU DP-44K DISP PUNCH 4.4MM
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 Key8574167
MDR Text Key144121989
Report Number3004365956-2019-00117
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Reporter Country CodeGR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 04/19/2019
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 Date07/22/2022
Device Catalogue NumberDP-44K
Device Lot Number74H1701864
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/19/2019
Initial Date FDA Received05/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/15/2017
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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