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

Catalog Number	011-C3300
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The complaint/event involved a clave¿ neutral connector that was reported as faulty and unable to be cleaned effectively prior to administration/infusion.This was due to the middle part (bung) had popped in on itself, and dust and dirt was collecting inside the bung.The patient was receiving treatment for a central line infection at the time of the complaint/event.The bung was changed out/replaced when the defect was noted.Subsequent to the initial complaint report, the customer provided additional information confirming that the patient was being treated for a central line infection prior to the complaint event and that they are not alleging a central line bloodstream infection as a result of the complaint.The customer stated that there was no patient harm since device was changed out/replaced.
Additional Manufacturer Narrative
Three samples of list #011-c3300, clave¿ neutral connector (one new and two used) were returned for evaluation.As received, the two used samples were returned with a silicone stuck down condition.No additional damage or anomaly was observed.No mating devices were returned.The used microclaves were disassembled and dry spike conditions were confirmed in both microclaves.No additional damage or anomalies were observed.The customer's complaint of silicone sleeve stuck down can be confirmed.The probable cause is typically due to an error during the lubrication manufacturing process.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 12jun2024.

• Brand Name: CLAVE¿ NEUTRAL 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: 19494836
• Report Number: 9617594-2024-00744
• Device Sequence Number: 8785771
• Product Code: FPA
• UDI-Device Identifier: 00840619001421
• UDI-Public: (01)00840619001421(17)280801(10)13742555
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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-C3300
• Device Lot Number: 13742555
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 06/08/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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
• Patient Sex: Male