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	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The event involved a clave¿ connector iv bag access device where it was reported that a spillage of 5-fluorouracil (5-fu) to the detriment of the healthcare worker c.C.Due to a failure of the clave connector device to seal.There was no patient involvement, it occurred during the preparation of the chemotherapy product.There was no human harm, no clinical consequences except the fact that the preparator reported a slight redness in the area of contact with the chemotherapy and he visited emergency department, no death, no blood loss, no delay in critical therapy and no medical intervention.The health condition of the preparator before and after the event did not change.The problem occurred during preparation.The chemo came into contact with the operator's left hand.The spill was cleaned up per protocol, but a spill kit was not used.The manufacturer of the solution container is baxter.The bag containing 5-fu was disposed of and replaced with a new one.
Additional Manufacturer Narrative
Received one new.List #011-cs-10, clave¿ connector iv bag access device, as received, no physical damage or other anomalies observed.The failed used sample was not returned for evaluation.Accessed the returned new 011-cs-10, clave with an approved icu medical syringe, no evidence of stick down or other anomalies.The returned new 011-cs-10 was attached to an iv bag; this was primed and hydrostatically pressure leak tested as received, the 011-cs-10 primed and did not leak.Unable to confirm customer complaint without the return of the failed device.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.D9: device returned to manufacturer on: 3/20/2025.

• 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: 21379444
• Report Number: 9617594-2025-00288
• Device Sequence Number: 8273560
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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
• Patient Sex: Unknown