MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 46" (117 CM) 50 ML, DILUENT SET FOR CHANNEL 2 W/20 DROP DRIP CHAMBER, SPIROS®; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH4002
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.Additional contact phone : (b)(6).
Event or Problem Description
The event involved a 46" (117 cm) 50 ml, diluent set for channel 2 w/20 drop drip chamber, spiros® where it was reported the syringe contains impurities, which are present due to the color discrepancy between the connector and the impurities, indicating contamination from non-use." the event occurred during medication preparation.It was also mentioned that there was no concomitant drug, no concomitant device, no bleed-back, with unknown name of chemo drug, no bio-hazard and unknown user facility med-watch.The device was not reprocessed/resterilized.There was no patient involvement, no adverse event/patient harm and no delay in critical therapy.
Additional Manufacturer Narrative
Received one used ch4002 diluent set for inspection.Unknown chemo drug solution residuals were observed throughout the set.The color and appearance of the fluid residuals appeared the same throughout the set.The reported complaint could not be confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 46" (117 CM) 50 ML, DILUENT SET FOR CHANNEL 2 W/20 DROP DRIP CHAMBER, SPIROS®
• 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: 19665335
• Report Number: 9617594-2024-00867
• Device Sequence Number: 12491120
• Product Code: ONB
• UDI-Device Identifier: 00840619054786
• UDI-Public: (01)00840619054786(17)281001(10)13659713
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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: CH4002
• Device Lot Number: 13659713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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