MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. NEUROTHERM¿ CLASSIC CURVED RF NEEDLE, 22G, 10CM; RF CANNULA

Model Number C-1005-S

Device Problems Nonstandard Device (1420); Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis; however further investigation revealed the incorrect tip length setting was used during manufacturing.

Event Description

Related manufacture ref number: 2182269-2019-00196, 2182269-2019-00197, 2182269-2019-00198, 2182269-2019-00199, 2182269-2019-00200, 2182269-2019-00201, 2182269-2019-00202, 2182269-2019-00203, 2182269-2019-00204, 2182269-2019-00205, 2182269-2019-00206, 2182269-2019-00207, 2182269-2019-00208, 2182269-2019-00209, 2182269-2019-00210, 2182269-2019-00211, 2182269-2019-00212, 2182269-2019-00213, 2182269-2019-00214, 2182269-2019-00215, 2182269-2019-00216, 2182269-2019-00217, 2182269-2019-00218, 2182269-2019-00219, 2182269-2019-00220, 2182269-2019-00221, 2182269-2019-00222, 2182269-2019-00223, 2182269-2019-00224, 2182269-2019-00225, 2182269-2019-00226, 2182269-2019-00227, 2182269-2019-00228, 2182269-2019-00229, 2182269-2019-00230, 2182269-2019-00231, 2182269-2019-00232, 2182269-2019-00233, 2182269-2019-00234, 2182269-2019-00235.Upon opening the box at the customer site, the label indicated a 5 mm tip and the product inside was a 10 mm tip.

• Brand Name: NEUROTHERM¿ CLASSIC CURVED RF NEEDLE, 22G, 10CM
• Type of Device: RF CANNULA
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9342530
• MDR Text Key: 182761175
• Report Number: 2182269-2019-00199
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 05415067028693
• UDI-Public: 05415067028693
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Model Number: C-1005-S
• Device Lot Number: 6865795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA-Q419-NM_EP-2
• Patient Sequence Number: 1