MAUDE Adverse Event Report: TELEFLEX MEDICAL, INC.; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Catalog Number MDP-44K

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2017

Event Type  malfunction  

Event Description

While surgeon was trying to punch hole in the aorta, the disposable aortic punch size 4.4 mm fell apart.A new product was obtained.There was no harm to the patient.

• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): TELEFLEX MEDICAL, INC.; 3015 carrington mill boulevard; morrisville NC 27560
• MDR Report Key: 7205324
• MDR Text Key: 97764153
• Report Number: 7205324
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MDP-44K
• Device Lot Number: 74D1700916
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 110