MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.62 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 4 CLA; STOPCOCK, I.V. SET

Model Number MC330479

Device Problems No Flow (2991); Physical Resistance/Sticking (4012)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

The event involved a 7" (18 cm) appx 0.62 ml, smallbore quadfuse ext set w/4 microclave® clear, 4 clamps, luer lock, where it was reported the nanoclave remain depressed when trying to complete total parenteral nutrition (tpn) infusion procedure and ¿popped¿ causing an occlusion alarm.There was unknown patient involvement and unknown patient harm.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Manufacturer Narrative

Received: one used.List #mc330479, 7" (18 cm) appx 0.62 ml, smallbore quadfuse ext set w/4 microclave¿ clear, 4 clamps, luer lock; lot #13483933.One used.List #unknown, trifuse set, 3 microclave; lot #unknown.One used.List #unknown, infusion set; lot #unknown.One used.List #unknown, nacl 0.9% sodium chloride injection baxter 250 ml intravenous bag; lot #w3e0521.One used.List #unknown, bifuse set, 2 microclave; lot #unknown.One used.List #unknown, extension tubing; lot #unknown.One used.List #unknown, infusion set; lot #unknown.One used.List #unknown, bd 50 ml syringe; lot #unknown.One used.List #h938738, exactamix baxter healthcare 500 ml eva container with parenteral nutrition; lot #60423382.Two photos were shared by the customer, in one photo is observed a sheet of paper with a not clear explication about what is written and the second photo is a handwritten that looks to be the sequence of an event.One used sample list #mc330479 beside additional items parts of the set configuration were returned for evaluation.As received it was observed a stick down condition in 1 out of the 4 microclaves, no additional damage or abnormally were observed.The microclave was dissembled and no significant damage or residual outside the body was observed, the spike was well lubricated and the seal presented a tearing condition however, no significant damage was observed.Complaint of silicone sleeve stuck down can be confirmed based in the physical sample evaluation.However, the probable cause of stick down condition in the microclave is unknown.A device history review (dhr) lot #13483933 was reviewed and no non conformance were identified that might occasioned the condition reported in the complaint.Device received on 7/21/2023.

• Brand Name: 7" (18 CM) APPX 0.62 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 4 CLA
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17325379
• MDR Text Key: 320051502
• Report Number: 9617594-2023-00385
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709090200
• UDI-Public: (01)00887709090200(17)271201(10)13483933
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC330479
• Device Catalogue Number: MC330479
• Device Lot Number: 13483933
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• 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: TOTAL PARENTERAL NUTRITION, UNK MFR.