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

Catalog Number	C1000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a clave¿ connector where the customer reported that the device leaked during patient use.The customer stated that there was no apparent harm to the patient but s/he did get saturated clothing in lap and was exposed to a hazardous medication in the clinic.The center of the clave (white in color) appeared to be squashed back into the clave, and when the attached tubing was removed, the clave's white center usually returns to center to close but it stayed retracted.There was minimal delay in therapy.The infusion was stopped, the line was inspected and the clave was noted to be broken; the center of the clave appeared to be pushed back into the clave when line was attached.Infusion was in process for approximately 5 minutes; using chemo precautions primary line was replaced and patient changed clothing.The faulty equipment was bagged and given to the floor manager.The customer further reported that the icu medical 360 plum pump was used.Although there was patient involvement, harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Additional Manufacturer Narrative
One (1) used.List #c1000, clave¿ connector with one (1) used.Spiros and one (1) used partial tubing and luer were returned for evaluation.As received, a stickdown was observed on the clave.No other damage or anomalies were observed on the clave or the spiros.The sample was primed and flow restriction was noted, the clave was dissembled and a crushed spike, tip anomaly, and torn seal were observed.No additional damage or anomalies were confirmed.The complaint of stickdown can be confirmed.The probable cause is due to a salt lake city molding defect.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22653735
• Report Number: 9617594-2025-01557
• Device Sequence Number: 8862941
• Product Code: FPA
• UDI-Device Identifier: 00840619069896
• UDI-Public: (01)00840619069896(17)290901(10)14146938
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: C1000
• Device Lot Number: 14146938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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: UNSPECIFIED CHEMOTHERAPY, MFR UNK
• Patient Sex: Unknown