MAUDE Adverse Event Report: ICU MEDICAL, INC. TEGO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	D1005
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As rn was connecting patient to evening chemotherapy, the tego cap that was attached to patient central line broke within the closed system transfer device (spiros) of chemotherapy tubing.Rn disconnected and replaced tego cap attached to patient, requested new dose of chemotherapy from pharmacy, and disposed of unusable medication with broken tego cap.Patient chemo was administered later than intended time due to this complication.
Event or Problem Description
As rn was connecting patient to evening chemotherapy, the tego cap that was attached to patient central line broke within the closed system transfer device (spiros) of chemotherapy tubing.Rn disconnected and replaced tego cap attached to patient, requested new dose of chemotherapy from pharmacy, and disposed of unusable medication with broken tego cap.Patient chemo was administered later than intended time due to this complication.

• Brand Name: TEGO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 13558829
• Report Number: 13558829
• Device Sequence Number: 14373779
• Product Code: FPA
• UDI-Device Identifier: 00840619069216
• UDI-Public: 00840619069216
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2022
• Report Date (Section F): 02/03/2022

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: D1005
• Device Catalogue Number: D1005
• Device Lot Number: 5497823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2022
• 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: Unknown
• Date Report Sent to FDA: 02/03/2022