MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/5" (13 CM) ADD-ON SET W/CHEMOLOCK¿ ADDITIVE PORT, VENTED CAP; CHE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3538
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - (b)(6).The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.
Event or Problem Description
The event involved an oncology kit w/5" (13 cm) add-on set w/chemolock¿ additive port, vented cap; chemolock¿; spinning spiros® w/red cap.The customer stated that the leak seemed to be coming from the juncture of the spiros and line; it is unclear if they are coming from the distal end of the spiros that connects to the patient, or the proximal end that connects to the primary tubing, but it is believed to be proximal end that connects to the primary tubing.There was patient involvement but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Three picture were returned.Pictures 1 and 2 showed a spiros that appeared to not be fully connected to the male luer end of an unknown mating device.At the connection of the unknown mating device and the spiros, what appears to be a droplet of fluid can be seen.Picture 3 showed a the back labeling of a baxter set package.The complaint of 'few recent chemo spills' can be confirmed based on the returned images.The luer connection does not appear to be adequate in the image.However, without the return of the used product a probable cause cannot be determined.A lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: ONCOLOGY KIT W/5" (13 CM) ADD-ON SET W/CHEMOLOCK¿ ADDITIVE PORT, VENTED CAP; CHE
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19634924
• Report Number: 9617594-2024-00845
• Device Sequence Number: 7093044
• Product Code: ONB
• UDI-Device Identifier: 00887709071902
• UDI-Public: (01)00887709071902
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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 Catalogue Number: CL3538
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown