MAUDE Adverse Event Report: CAREFUSION 2200, INC. TEMNO EVOLUTION COAXIAL W/18 G X 15 CM NDL; BIOPSY NEEDLE

Model Number CTT1815

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2017

Event Type  malfunction  

Event Description

A woman was undergoing a liver biopsy in interventional radiology.The introducer was the correct size but the biopsy gun was 10 cm even though it was taken out of a 15 cm package.There are no size identifiers on the device itself.The lines on the needles can be counted - 1 line = 1 cm.Given that gun didn't reach the area to be biopsied, the physician switched to another biopsy gun.There was no harm to the patient.Manufacturer response for biopsy gun, temno evolution coaxial w/18 g x 15 cm ndl (per site reporter).On june 13th the radiology manager asked for follow-up.The company responded that the concern had been forwarded to the manufacturing site where it is being evaluated.According to the company's quality specialist the process can take up to 90 days.

• Brand Name: TEMNO EVOLUTION COAXIAL W/18 G X 15 CM NDL
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): CAREFUSION 2200, INC.; 400 east foster rd.; mannford OK 74044
• MDR Report Key: 6696447
• MDR Text Key: 79369759
• Report Number: 6696447
• Device Sequence Number: 1
• Product Code: FCG
• 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: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: CTT1815
• Device Catalogue Number: CTT1815
• Device Lot Number: 0000998280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 54 YR