MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL-13
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a chemolock¿ bag spike with additive port that experienced leakage.The reporter stated that they had a leak on friday originating from where the chemo lock port attaches to the bag access spike on the cl-13.The drug involved was cyclophosphamide.The customer stated also that the angle of the chemolock doesn¿t appear to be fully perpendicular.Sample photo was provided showing the sample.
Additional Manufacturer Narrative
D4 and h4 the lot#, expiration date, and manufacture date are unknown.The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Investigation summary: a photo was provided showing the cl-13 in a plastic bag attached to a clave.The clave was submerged in fluid and a break was observed at the chemolock side port.The reported complaint of leakage can be confirmed due to the break on the side port.The probable cause of the break is unknown.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history record could not be reviewed due to the unknown lot number.

• Brand Name: CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT
• 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: 21639110
• Report Number: 9617594-2025-00504
• Device Sequence Number: 8510977
• Product Code: ONB
• UDI-Device Identifier: 00887709056985
• UDI-Public: 00887709056985
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: CL-13
• Device Lot Number: NOT PROVIDED
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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