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

Model Number 011-C3300

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 07/03/2023

Event Type  malfunction  

Event Description

The incident involved a microclave® connector.The fluid leaked from the silicone site.The name of the involved drug was unknown.There was no physical damage noted on the device.The set was replaced and the therapy resumed.There was patient involvement, no adverse event/patient harm and no delay in critical therapy.

Manufacturer Narrative

Internal leakage was confirmed coming from the used 011-c3300 microclave connector.When the used 011-c3300 microclave connector was disassembled a seal rupture was observed and noted to be in-line with the slit on the top surface of the seal.There was no evidence of a needle strike.The probable cause of the seal rupture is a slitter malfunction during seal cutting in automated assembly in salt lake city resulting an axial cut in the seal and subsequent leakage.The lot history of the provided packaging was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: MICROCLAVE® 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17371795
• MDR Text Key: 319878295
• Report Number: 9617594-2023-00427
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K970855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2023

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 Model Number: 011-C3300
• Device Catalogue Number: 011-C3300
• Device Lot Number: 5189594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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: UNKNOWN DRUG, UNK MFR