MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT, 10 UNITS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL-13-10
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The incident involved a chemolock¿ bag spike with additive port.It was reported that there was a white, particulate substance in the tubing.The product was not reprocessed or re-sterilized prior to use.The event happed upon removal from original packaging.There was no patient involvement, no human harm or adverse event and no delay in therapy.This is the third of six reports.
Additional Manufacturer Narrative
The samples returned were confirmed to have white solvent residuals at the bond between the white spike and the clear tubing.The white solvent residuals were internal to the clear tubing but were adhered to the inside of the tubing and could not be made to shed particulate.The white solvent residuals are bonded to the inside of the tubing and are a cosmetic anomaly which does not break down or shed into particulate.The probable cause of the white solvent residuals inside the adapter tubing is excessive solvent applied during manual assembly in ensenada.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9: device returned to manufacturer on 14-jul-2023.

• Brand Name: CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT, 10 UNITS
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17315498
• Report Number: 9617594-2023-00365
• Device Sequence Number: 17142813
• Product Code: ONB
• UDI-Device Identifier: 00887709079045
• UDI-Public: (01)00887709079045(17)271101(10)10619793
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/28/2023

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: CL-13-10
• Device Catalogue Number: CL-13-10
• Device Lot Number: 10619793
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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