MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 72" (183 CM) APPX 1.7 ML, PUR YELLOW SMALLBORE EXT SET W/MICROCLAVE® CLEAR, 1.2; STOPCOCK, I.V. SET

Catalog Number MC330217

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/13/2023

Event Type  malfunction  

Event Description

It was reported in the medwatch report (uf/importer report# (b)(4)) that stated: "tubing used for lipids was found to be leaking beneath the leur lock/clave device where it connected to the tubing itself.Faulty equipment bagged with a piece of tape indicating where the malfunction occurred." the device involved in the event is a 72" (183 cm) appx 1.7 ml, pur yellow smallbore ext set w/microclave® clear, 1.2 micron filter, clamp, luer lock being used in the skilled nursing unit.The originally intended procedure was for intravenous (iv) chemotherapy, iv hydration, and antiemetic support.There was no patient harm reported.

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Manufacturer Narrative

Medwatch attachede4 - initial report sent to fda.

Manufacturer Narrative

Received one (1) used mc330217 pur yellow smallbore ext set for inspection.When the returned syringe was disconnected from the microclave, a stickdown was observed.The seal rebounded after some time of being undisturbed.The set was leak-tested per product specifications.A channel leak was observed at the tubing to the bond interface of the microclave.A bond integrity test was conducted at the channel leak bond.The bond failed product specifications.The tubing and bond pocket were measured and found to have met dimensional specifications.The reported complaint of leakage can be confirmed.The probable cause is due to insufficient solvent coverage applied during manual assembly.The microclave was disassembled and was found to have a dry spike tip.The probable cause of the temporary stick down is due to insufficient lubrication applied on the internal spike during assembly.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 72" (183 CM) APPX 1.7 ML, PUR YELLOW SMALLBORE EXT SET W/MICROCLAVE® CLEAR, 1.2
• 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: 18813572
• MDR Text Key: 336962765
• Report Number: 9617594-2024-00219
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2024

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: MC330217
• Device Lot Number: 8602027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 02/01/2024; 03/08/2024
• Supplement Dates FDA Received: 02/29/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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: UNSPECIFIED LIPIDS, UNK MFR.
• Patient Age: 4 MO
• Patient Sex: Male
• Patient Weight: 7 KG