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	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.However, photographs was provided by the customer and evaluation of the photos are pending.
Event or Problem 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.
Additional 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
• 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: 18235043
• Report Number: 9617594-2023-01044
• Device Sequence Number: 19659678
• Product Code: FPA
• UDI-Device Identifier: 00840619000011
• UDI-Public: (01)00840619000011(17)271101(10)11747092
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 011-C1000
• Device Lot Number: 11747092
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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: DOXORUBICIN, MFR UNK
• Patient Sex: Unknown