MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE¿ CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	C1000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for investigation.Investigation is pending.
Event or Problem Description
The event occurred on an unspecified date and involved a clave¿ connector where it was reported the device leaked chemotherapy during infusion and came in contact with the patient and nurse.It was reported that the connection was coming apart for no reason.The line was not pulled on and spontaneously detached from the tubing line.The disconnection occurred at the connection site between connector and either the tubing of port or the primary tubing.The set up was the connector was connected directly on the end of either the patient¿s port line or peripheral intravenous (iv) line.The primary tubing was then connected into the luer lock of the connector.The connector and tubing was replaced and the therapy was resumed.There was patient involvement and a delay in therapy, however no report of patient harm.This captures the second of two occurrences.
Additional Manufacturer Narrative
Received fifty new.List #c1000, clave¿ connector; lot #8089218.List #c1000, clave¿ connector; lot #8089218.Thirty-five of the fifty new list #c1000, clave¿ connector; lot #8089218 were selected.No damages or anomalies noted.No mating device were returned for evaluation.No used samples were returned for evaluation.The samples were leak tested per product specification.There were no leaks and no disconnections observed.The returned sample met product iso measurement and product specifications.The complaint of disconnection could not be confirmed or replicated on the returned tested devices.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.E1 initial reporter phone number: (b)(6).

• Brand Name: CLAVE¿ CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 16334137
• Report Number: 9617594-2023-00070
• Device Sequence Number: 6845036
• Product Code: FPA
• UDI-Device Identifier: 00840619069896
• UDI-Public: (01)00840619069896(17)270801(10)8089218
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K970855
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2023

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: C1000
• Device Catalogue Number: C1000
• Device Lot Number: 8089218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLUOROURACIL, UNK MFR.
• Patient Sex: Unknown