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

Model Number	CH-12
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a chemoclave® bag spike with additive port dry spike where it was reported that the set was disconnected during patient infusion.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
The device is not available for investigation.However, a photo was provided by the customer to be evaluated.The investigation is not yet complete.
Additional Manufacturer Narrative
The complaint of separation can be confirmed based on the photos provided.Received a photo showing the chemoclave separated from the bag spike assembly.No samples were returned for evaluation.The base of the chemoclave cannot be observed in the photo provided.The probable cause of the separation is unknown.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history report (dhr) for lot 13408810 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE
• 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: 17343921
• Report Number: 9617594-2023-00397
• Device Sequence Number: 17785287
• Product Code: ONB
• UDI-Device Identifier: 00840619023713
• UDI-Public: (01)00840619023713(17)271201(10)13408810
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2023

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: CH-12
• Device Catalogue Number: CH-12
• Device Lot Number: 13408810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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