MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-40K DISP PUNCH 4.0MM

Catalog Number DP-40K

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record of batch number (b)(4) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.The device sample has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: the device would not cut completely through the vessel and it was difficult to remove.The aorta was torn during removal and required repair with stitches.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).The lot number 74b150135b is not valid at the manufacturing facility; the correct lot number is 74b1501358.The device history record of batch number 74b1501358 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.

Event Description

Alleged event: the device would not cut completely through the vessel and it was difficult to remove.The aorta was torn during removal and required repair with stitches.The patient's condition was reported as fine.

• 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 Key: 4963815
• MDR Text Key: 23404308
• Report Number: 3004365956-2015-00193
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DP-40K
• Device Lot Number: 74B150135B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention