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

Catalog Number	CL-10
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it has not yet been received.
Event or Problem Description
The event involved a chemolock¿ bag spike where it was noted that blue particulate can be seen on the spike.It was noted that they used a 500 ml fresenius kabi 0.9% sodium chloride injection, non-dehp bags.The event was noted during compounding inside the bsc.There was no patient involvement, and no human harm.
Additional Manufacturer Narrative
Received one used cl-10 for inspection.No defects or anomalies were observed.The spike was measured and found to meet dimensional specifications.The cl-10 was flushed with fluid and no particulate was collected.However, there was stovepipe flash observed on the port of the iv bag that could lead to particulates.The reported complaint can be confirmed due to the stovepipe flash found on the iv bag.The probable cause of the small blue flash inside the iv bag is due to stovepipe flash present on the blue freeflex iv bag port that was transferred to the white bag spike when the bag spike was inserted into the blue freeflex iv bag port.The iv bag is a non-icu medical product.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CHEMOLOCK¿ BAG SPIKE
• 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: 21379774
• Report Number: 9617594-2025-00289
• Device Sequence Number: 20947885
• Product Code: ONB
• UDI-Device Identifier: 00887709056961
• UDI-Public: (01)00887709056961(17)290201(10)13893943
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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-10
• Device Lot Number: 13893943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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