MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15 CM (6") APPX 0.35 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMP; STOPCOCK, I.V. SET

Catalog Number 011-MC3322

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however, has not yet been received.Additional reporter: (b)(6).

Event Description

The event occurred on various dates between (b)(6) 2023 in the intensive care ward.The event involved a 15 cm (6") appx 0.35 ml, smallbore bifuse ext set w/2 microclave¿ clear, 2 clamps, rotating luer where it was reported patients have not received medication due to leakage in the luer lock coupling to the svk/pvk.This occurred during continuous infusions using syringe volume pumps.The defect was visible, and the location of the defect was in the luer lock.The patient/ health care provider were treated with painkillers.After using the product, the cracks were detected.There was patient involvement but no patient harm.

Manufacturer Narrative

A series of photos were shared by the customer, where an used opened packaged item #011-mc3322 is observed broken the male luer, no additional damage or anomalies are observed on the photo.One new sample item # 011-mc3322 was returned for evaluation, as received no physical damage or anomalies were visually observed on the sealed product.No mating devices were returned.The sample was tested as per procedure and no leaks, occlusions or anomalies were confirmed after priming.Complaint of leaks cannot be confirmed or replicated.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.D9: device returned to manufacturer on 2/19/2024.

• Brand Name: 15 CM (6") APPX 0.35 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMP
• Type of Device: STOPCOCK, I.V. SET
• 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: 18667346
• MDR Text Key: 334850347
• Report Number: 9617594-2024-00121
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC3322
• Device Lot Number: 13498374
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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: SYRINGE VOLUME PUMP, UNK MFR