MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-48K DISP PUNCH 4.8MM; INSTRUMENTS,SURGICAL,CARDIOVASC

Catalog Number DP-48K

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record of the batch number provided has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No rejection report was originated for the lot in question that can be associated to the complaint reported.The device history review shows that the product was assembled and inspected according to our specifications.The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.

Event Description

The aortic punch misfired during a cardiac procedure.There was no patient injury.

Manufacturer Narrative

(b)(4).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.Based on the testing performed to the available sample, customer complaint is not confirmed since the unit was not found to be out of specifications.Dimensional testing according to (b)(4) was performed to the metal components once disassembled obtaining acceptable dimensional results.Dimensional testing according to (b)(4) was performed to the metal components once disassembled obtaining acceptable dimensional results.No corrective actions can be established since the visual, dimensional and functional test demonstrated that product is according to the specifications.

Event Description

The aortic punch misfired during a cardiac procedure.There was no patient injury.

• Brand Name: PU DP-48K DISP PUNCH 4.8MM
• Type of Device: INSTRUMENTS,SURGICAL,CARDIOVASC
• 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: 6700721
• MDR Text Key: 79646617
• Report Number: 3004365956-2017-00282
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2017

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 Date: 12/26/2021
• Device Catalogue Number: DP-48K
• Device Lot Number: 74M1602092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/11/2017
• Supplement Dates Manufacturer Received: 02/12/2018
• Supplement Dates FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2016
• 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