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

Catalog Number	CH-13
Medical Device Problem Codes	Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
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 complaint/event involved a chemoclave® bag spike with additive port.A nurse reported air filling into the additive port and found leakage of a chemo drug after disconnection.The patient was not harmed, a spill kit was used to clean the chemo leakage, and the procedure was delayed for 15 minutes.
Additional Manufacturer Narrative
A series of photos were shared by the customer, where a stick down condition was observed on the sample.Another photo showed a carton box, however no additional damage was observed from the photographs provided.One used sample (list #ch-13) was returned for evaluation.As received, a silicone plug was stuck down as confirmed.No additional damage or anomalies were observed.No mating devices was returned.No mating devices was returned.Once the clave was dissembled a spike bent and torn seal conditions were confirmed.Complaint of leakage can be confirmed based on the spike bent condition.The probable cause is typically due to access with an incompatible mating device during use.The dfu states: the clave connector is compatible with luers with an internal diameter (id) between 1.55 mm and 2.8 mm.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 02jan2024.

• Brand Name: CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT
• 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: 18441313
• Report Number: 9617594-2024-00009
• Device Sequence Number: 8114518
• Product Code: ONB
• UDI-Device Identifier: 00840619023737
• UDI-Public: (01)00840619023737(17)280501(10)13635152
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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: CH-13
• Device Lot Number: 13635152
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CHEMOTHERAPY, MFR UNK
• Patient Sex: Unknown