MAUDE Adverse Event Report: TELEFLEX INCORPORATED PILLING; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number IPN915270

Patient Problem Insufficient Information (4580)

Event Date 01/02/2024

Event Type  malfunction  

Event Description

Seven reports of the disposable aortic punch getting stuck.Event date with lot number: [date redacted]: #74g2301617; [1 week after 1st event]: #74g2301117; [10 days after 1st event] x2,: #74g2301617 and #74h2300962; [2 weeks after 1st event]: unknown lot number, [17 days after 1st event]: #74h2300962, [29 days after 1st event]: unknown lot number.

• Brand Name: PILLING
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 18777033
• MDR Text Key: 336207011
• Report Number: 18777033
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 14026704697943
• UDI-Public: (01)14026704697943
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/09/2024

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 Model Number: IPN915270
• Device Catalogue Number: DP-40K
• Device Lot Number: 74G2301617, 74G2301117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1