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

Catalog Number 011-C1000

Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2023

Event Type  malfunction  

Event 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.

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).

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 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
• Type of Device: 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
• MDR Text Key: 323505150
• Report Number: 9617594-2023-00716
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619000011
• UDI-Public: (01)00840619000011(17)271001(10)10986023
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K970855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 011-C1000
• Device Lot Number: 10986023
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ADMINISTRATION SET. MFR UNK
• Patient Sex: Male