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

Catalog Number	B30140
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
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 event involved a 97" transfer set w/graduated adapter, 1 ext where it was reported there were particles in an infusion bag using pembrolizumab (from foreign distributor servier bulgaria) in a clinical study.Infusion was prepared a 2nd time with new pembro vials, whereby particles were observed again.Infusion was prepared a 3rd time, this time with syringe and needle and no particles observed.Medication involved was pembrolizumab (servier bulgaria) in nacl 0.9% 100 ml infusion.The event occurred during reconstitution of the imp, i.E.Particles were formed upon time of dilution of the concentrated imp pembrolizumab into the saline infusion bag.The device was changed out/replaced with no further problems encountered.There was patient involvement but indirect and patient was not harmed, only delay of therapy and infusion bag with particles was not dispensed nor administered.This report captures 2 occurrences.
Additional Manufacturer Narrative
Investigation summary the complaint of particles in an infusion bag on item 011-ch2000s cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.A device history lot review was performed.However, no anomalies, nonconformances were found that might be related with the condition reported by customer.

• Brand Name: SPINNING 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: 22367863
• Report Number: 9617594-2025-01401
• Device Sequence Number: 15446686
• Product Code: ONB
• UDI-Device Identifier: 00887709004597
• UDI-Public: (01)00887709004597(17)291001(10)14160660
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 08/15/2025

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: B30140
• Device Lot Number: 14160660
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PEMBROLIZUMAB IN NACL 0.9% 100 ML INFUSION
• Patient Sex: Unknown