MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-40K DISP PUNCH 4.0MM; INSTRUMENTS, SURGICAL, CARDIOV

Catalog Number DP-40K

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.A complaint history review was conducted on the catalog number in question.No complaints were received in this range with the same issue.Since the lot number provided (2400021) is not valid a dhr review could not be completed.The customer complaint cannot be confirmed since a product sample was not provided to perform a proper investigation and determine a root cause.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during a cabg the physician had to push the aortic punch twice instead of once to punch through the aorta.

• Brand Name: PU DP-40K DISP PUNCH 4.0MM
• 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 Key: 7999568
• MDR Text Key: 124833540
• Report Number: 3004365956-2018-00315
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: RP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2018

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 Catalogue Number: DP-40K
• Device Lot Number: 2400021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 10/24/2018
• 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 Number: 1