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 Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.However, photographs was provided by the customer and evaluation of the photos are pending.

Event Description

The complaint/event involved a clave® connector.The head of oncology at the hospital reported that the set disassembled during treatment (after approximately one hour).Microdroplets in pink color (doxorubicin) was observed on the membrane side.The problem was noticed during handling at the moment of disconnection after treatment.Although there was a patient involved, there was no delay in therapy, no adverse event and no one harmed as a result of this event.Neither the patient nor the clinical professional were in contact with the fluid, because the incident was detected and the device was disposed of using protective measures.

Manufacturer Narrative

Two photos were shared by the customer.The first photo illustrated a microclave with small drops coming from the seal.However, the pink color described by customer was not observed.The second photo showed the label information with lot number and item description.No additional damages were observed.The device history record was reviewed and no non conformities were found that would have led the reported condition on the complaint.Additional information can be found in h6 medical device problem code.

• 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: 18235043
• MDR Text Key: 329344162
• Report Number: 9617594-2023-01044
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619000011
• UDI-Public: (01)00840619000011(17)271101(10)11747092
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K970855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/31/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 011-C1000
• Device Lot Number: 11747092
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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: DOXORUBICIN, MFR UNK