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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
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TELEFLEX MEDICAL PU DP-48K DISP PUNCH 4.8MM Back to Search Results
Catalog Number DP-48K
Device Problem Sticking (1597)
Patient Problems Tissue Damage (2104); No Consequences Or Impact To Patient (2199)
Event Date 04/10/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.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.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that during use of the disposable aortic punch, the punch became stuck resulting in an iliac artery tear and the need to perform an additional intraoperative procedure to repair the artery.The patient did well post-procedure.
 
Event Description
It was reported that during use of the disposable aortic punch, the punch became stuck resulting in an iliac artery tear and the need to perform an additional intraoperative procedure to repair the artery.The patient did well post-procedure.
 
Manufacturer Narrative
Qn# (b)(4).Sample was received without its original package (pouch) instead sample was received on a (b)(6) bag with a disinfection tag.Per visual inspection, blade and core are jammed.Signs of lodged tissue are visible in the punch.While attempting to disengage the punch by hand, the blade and core release the jam, confirming that a portion of tissue was causing the jam in the punch.The tissue was removed and cleaned from the tip of the punch in order to review its functionality.A cut with a pork aorta was performed and the punch performed correctly, no signs of jam were detected.Based in the analysis performed, the lodged tissue was removed from the punch and then the punch performed correctly.Customer complaint is not confirmed due to a failure to follow ifu steps 3 and 4 which states that excised tissue has to be removed prior performing another opening.Manufacturing personnel was notified of this event for awareness.
 
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Brand Name
PU DP-48K DISP PUNCH 4.8MM
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key7590498
MDR Text Key110709615
Report Number3004365956-2018-00184
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/11/2022
Device Catalogue NumberDP-48K
Device Lot Number74K1700915
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2018
Date Manufacturer Received07/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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