MAUDE Adverse Event Report: TELFLEX MEDICAL PU DP-48K DISP PUNCH 4.8MM; NONE

Catalog Number DP-48K

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

Alleged event: the punch jammed in the closed position and would not open.The surgeon had to dissect around it and to remove.The vessel was still viable and case successful.The pt's condition is reported as fine.

Manufacturer Narrative

(b)(4).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 complaints.

• Brand Name: PU DP-48K DISP PUNCH 4.8MM
• Type of Device: NONE
• Manufacturer (Section D): TELFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 8827 5; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 4317152
• MDR Text Key: 17571418
• Report Number: 3004365956-2014-00399
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2014

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?: No
• Device Operator: Other
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: DP-48K
• Device Lot Number: 02K1300158
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/21/2014
• Initial Date FDA Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention