MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. EXT SET, SMALLBORE WITH CLAVE¿; STOPCOCK, I.V. SET

Catalog Number	011-C3302
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.Section e additional contact: (b)(6).
Event or Problem Description
The complaint/event involved a ext set, smallbore with clave¿.It was reported that the device does not connect tightly and the tubing popped off during a patient's infusion of an unspecified infusate; however, there was no medication involved.There was no concomitant drug and no concomitant device.There was no specific physical damage noted on the set.The set was replaced and therapy resumed without any problem.There was no leakage, no any unprotected chemotherapy exposure to the patient, health care worker or other personnel, no interventions done due to spillage, no chemo spill was cleaned up per facility protocol, and no spill kit used.The set was replaced and therapy resumed without any problem.There was no adverse event/patient harm and no delay in critical therapy.
Additional Manufacturer Narrative
Received one used 011-c3302 ext set for inspection.No defects or anomalies noted.The connection of the male luer to an icu medical provided female luer was functionally tested and found to have met performance expectations.The male luers were measured and found to be iso compliant.The reported complaint could not be replicated or confirmed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: EXT SET, SMALLBORE WITH CLAVE¿
• 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 ; CS 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20434375
• Report Number: 9617594-2024-01437
• Device Sequence Number: 8440630
• Product Code: FMG
• UDI-Device Identifier: 00840619001537
• UDI-Public: (01)00840619001537(17)281001(10)13796638
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K964435
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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-C3302
• Device Lot Number: 13796638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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 INFUSATE, MFR UNK.
• Patient Sex: Unknown