MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5.5" (14 CM) APPX 0.55 ML, SMALLBORE TRIFUSE EXT SET W/3 CHEMOCLAVE®, SPIROS® W/; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3700
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 5.5" (14 cm) appx 0.55 ml, smallbore trifuse ext set w/3 chemoclave¿, spiros¿ w/red cap, 3 clamps the reported issue was trifuse tubing disconnected from bonded spiros.Ivf running at time of event.There was patient involvement and no harm.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
The reported complaint could not be confirmed.No product samples, pictures, or videos were received for investigation.Therefore, a comprehensive failure investigation cannot be performed and a cause cannot be determined.A manufacturing record review could not be completed as the lot number was not provided by the customer.

• Brand Name: 5.5" (14 CM) APPX 0.55 ML, SMALLBORE TRIFUSE EXT SET W/3 CHEMOCLAVE®, SPIROS® W/
• 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: 18611363
• Report Number: 9617594-2024-00069
• Device Sequence Number: 7565587
• Product Code: FPA
• UDI-Device Identifier: 00887709089181
• UDI-Public: 00887709089181
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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: CH3700
• Device Lot Number: UNKNOWN
• 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: 01/10/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: METHOTREXATE, MFR UNK; VINCRISTINE, MFR UNK
• Patient Sex: Unknown