MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE¿ CONNECTOR IV BAG ACCESS DEVICE; STOPCOCK, I.V. SET

Catalog Number	011-CS-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2025 has been used as a placeholder.Investigation summary: two (2) videos were provided for evaluation; both videos confirm the complaint of the spike leak.The probable cause is unknown without the return of the failed sample.The dhr for lot number 13992335 was reviewed, no relevant nonconformities observed that would have contributed to this complaint.
Event or Problem Description
A complaint was received regarding a clave¿ connector iv bag access device that experienced leakage during use.The following issue was reported by the customer: ¿the reporter stated that during the preparation of a bag of paclitaxel lot: 2513ik1 and expiry: 01/04/2025, after attaching the spike in question there was a loss of cta from the spike, not at the point of engagement, but in the lower part.There was no patient harm.The actual sample is not available, sample videos were provided.¿ in clarification to the above entry, there was a leak noticed from the spike.There was no blood loss.The patient was involved; however, no harm was reported.

• Brand Name: CLAVE¿ CONNECTOR IV BAG ACCESS DEVICE
• Common Device Name: STOPCOCK, I.V. SET
• 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: 21936411
• Report Number: 9617594-2025-00867
• Device Sequence Number: 17493898
• Product Code: FMG
• UDI-Device Identifier: 00840619005955
• UDI-Public: (01)00840619005955(17)290401(10)13992335
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K082836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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: 011-CS-10
• Device Lot Number: 13992335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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: PACLITAXEL LOT: 2513IK1, MFR UNKNOWN
• Patient Sex: Unknown