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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; INSTRUMENTS, SURGICAL, CARDIOV

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TELEFLEX MEDICAL PU DP-44K DISP PUNCH 4.4MM; INSTRUMENTS, SURGICAL, CARDIOV Back to Search Results
Model Number IPN915271
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device is reportedly not available for investigation.A visual nor functional inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided.The device history review could not be conducted since involved lot number was not provided.The customer complaint cannot be confirmed based only on the information provided; to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.An attempt to duplicate the failure mode 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.If the sample becomes available this investigation will be updated with the evaluation results.
 
Event Description
Note: this report represents other customer device reports with unknown details but reported as a similar event to the report below.While use in a cabg case, the surgeon was using the aortic punch and the instrument was slightly jammed/stuck on the tissue of the aorta when closed.The surgeon was able to dislodge and open then punch with no harm, but was concerned about its structure for future use.It has not happened in the last 2 months and may have been a certain box that was having this issue.They did not have the correct lot for these aortic punches used.They also told me they check and try the punches prior to use in a case.
 
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Brand Name
PU DP-44K DISP PUNCH 4.4MM
Type of Device
INSTRUMENTS, SURGICAL, CARDIOV
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville 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 Key12753916
MDR Text Key280260298
Report Number3004365956-2021-00303
Device Sequence Number1
Product Code DWS
UDI-Device Identifier14026704697950
UDI-Public14026704697950
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/20/2021
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 Model NumberIPN915271
Device Catalogue NumberDP-44K
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/20/2021
Initial Date FDA Received11/04/2021
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
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