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

Catalog Number	CH-10-10
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that a chemoclave® bag spike, (b)(4) units generated a leak during patient use.The report states that the sample was defective.No staff or patients were exposed to hazardous drugs.No medical attention is required for either staff or patients.The drug involved was cyclophosphamide and (b)(4).Drug dose, diluent, concentration 750mg/d5w 500ml 750mg in 551.75ml.The amount spilled was approximately 20 ml and no spill kit was used.The report states that the spikes break with the cyclophosphamide product branded avyxa.After the addition of medication, the spike was flushed.Medication was still in the chemo bag.Proper garbing was used to retrieve other medications in the same bag.The sample was available for evaluation.Sterile samples of the same lot # were available for testing.A sample photo was provided showing the sample and it seems that it was broken off.The customer does not use icu fluids, they use braun.There was no patient harm reported.
Additional Manufacturer Narrative
One (1) photograph was provided by the customer for evaluation.One photo confirms the complaint of the spike broken off.The customer complaint can be confirmed from the photograph provided.A probable cause cannot be identified based on the information that has been provided.The device history report (dhr) for lot number 14051967 was reviewed and there were no non-conformances found that would have contributed to the reported complaint.

• Brand Name: CHEMOCLAVE® BAG SPIKE, 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20582828
• Report Number: 9617594-2024-01548
• Device Sequence Number: 18321479
• Product Code: ONB
• UDI-Device Identifier: 00840619033859
• UDI-Public: (01)00840619033859(17)290601(10)14051967
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: CH-10-10
• Device Lot Number: 14051967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 500MG (838310116-01) WITH THE DILUENT OF 1300MG IN.; 765MG IN D5W 500ML (1.39MG/ML).; AVYXA 1000MG (83831-0117-02).
• Patient Sex: Unknown