MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC.; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM PRODUCT CODE: FOZ

Device Problem Material Fragmentation (1261)

Patient Problems Emotional Changes (1831); Pain (1994); Discomfort (2330)

Event Date 07/28/2018

Event Type  Injury  

Event Description

Information was received from a court complaint alleging that smiths medical peripheral venous catheter was placed in patient and following removal of the device a portion of the device remained in patient's arm.The complaint alleges that an x-ray examination showed portion of device remained in patient's arm and required surgical removal.

• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM PRODUCT CODE: FOZ
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9833528
• MDR Text Key: 183514886
• Report Number: 3012307300-2020-02025
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention