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

Catalog Number	011-C1000
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reported complaint occurred on an unspecified date and involved a clave® connector.It was reported that the patient's mother found her girl covered in blood due to leakage from the connection between the clave connector and the administration set.She identified that the clave connector was blocked at the small valve on the tip and the valve did not lift after use; it remained open and did not close.The device was immediately replaced.The complainant further stated that the patient lost a lot of blood which dirtied her undershirt, pajamas, and sheet.Although the patient was impacted, there were no consequences or harm as a result of the complaint/issue/event.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Section e, initial reporter's initials: (b)(6).Section e, additional contact: (b)(6).
Additional Manufacturer Narrative
No product samples were returned for investigation, however, a series of photographs were returned showing a 011-c1000 clave with the silicone seal stuck down.It was not possible to determine the probable cause of the stick down from the photos returned.A photo of the unit package label was also returned with no observable anomalies.Although the clave stick down was identified in the pictures, a detailed investigation could not be conducted and a probable cause of the clave stick down cannot be determined without return of the affected sample.
Event or Problem Description
Additional information was received on september 22, 2023, stating that the therapy (parenteral nutrition infusion) was completed, there were no delays, it is unknown how much blood he (the patient) lost, but the loss was considerable and sufficient to soil his mattress.

• 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: 17755756
• Report Number: 9617594-2023-00716
• Device Sequence Number: 15246960
• Product Code: FPA
• UDI-Device Identifier: 00840619000011
• UDI-Public: (01)00840619000011(17)271001(10)10986023
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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: Lay User/Patient
• Device Catalogue Number: 011-C1000
• Device Lot Number: 10986023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2020
• 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: ADMINISTRATION SET. MFR UNK
• Patient Sex: Male