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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a clave¿ connector that experienced leakage during infusion.The report states that during the past month a few incidents with the clave connecter blue knobs leaking.The hub becomes stuck unpredictably and leaks out fluid.The customer also stated that radioactive tracer leaking onto a patient's arm as a result.The date of incident was on (b)(6) 2025 during infusion.The procedures were completed.The tests were still diagnostic level.No delay in diagnosis or treatment.The clave was attached to a stop-cock which was attached to a series of tubing and other stop-cocks.It was not accessed with a blunt or sharp.It was accessed within the target area.The clave was directly connected to the patient's iv.The clave site was on peripheral iv - left acf.No impact on the patient or healthcare provider, only a small drop was spilled on the patient, the majority of the dose went through the iv and was collected in the patient's heart.The test was still diagnostic, and the patient did not receive any additional radiation as a result.No contamination was found on any surface afterwards.The radioactive spill was cleaned up per facility protocol.Spill kit was not necessary; the patient's arm was cleaned with an alcohol swab and the supplies were placed in radioactive garbage afterwards.The tracer did not contaminate any external surfaces.The leak occur approximately at the 5-minute mark, after persantine had been infused.The set-up was patient iv -> clave needleless connector -> stop cock -> 7" extension tubing -> stop cock -> 63" persantine extension set with rotating leur -> stop-cock -> 60 ml syringe.Saline was also used.There was no adverse event or human harm; the patient still received the same amount of radiation as was ordered for their test originally.The test was still of diagnostic accuracy and therefore did not need to be repeated.
Additional Manufacturer Narrative
E1: this complaint was received through: (b)(6).The device is not available for evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Investigation summary: the complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history was reviewed and no nonconformities were found that would have led 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: 22526801
• Report Number: 9617594-2025-01473
• Device Sequence Number: 9303171
• Product Code: FPA
• UDI-Device Identifier: 00840619069896
• UDI-Public: (01)00840619069896(17)290801(10)14105230
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 14105230
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2024
• 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: 60 ML SYRING, MFR UNKNOWN; 63" EXTENSION SET, MFR UNKNOWN; IV CATHETER, MFR UNKNOWN; PERSANTINE, MFR UNKNOWN; UNSPECIFIED 7" EXTENSION TUBING; UNSPECIFIED STOPCOCK, MFR UNKNOWN
• Patient Sex: Unknown