MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	305506
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Upon assessment of piv, it was noted that catheter was missing.Site assessed and felt as if catheter was still in patients arm.Ultrasound confirmed iv catheter retention.Clinical decision made noting the benefit of removing the foreign body did not outweigh the risk.

• Brand Name: JELCO
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 14512288
• Report Number: 14512288
• Device Sequence Number: 2478785
• Product Code: FOZ
• UDI-Device Identifier: 10351688071095
• UDI-Public: (01)10351688071095
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/13/2022
• Report Date (Section F): 05/13/2022

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
• Operator of Device: Health Professional
• Device Model Number: 305506
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 59 KG
• Date Report Sent to FDA: 05/13/2022