MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE®; STOPCOCK, I.V. SET

Catalog Number MC330419

Device Problems Fluid/Blood Leak (1250); Physical Resistance/Sticking (4012)

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

Event Date 05/26/2023

Event Type  malfunction  

Manufacturer Narrative

One used sample.List #mc330419 was returned for evaluation, as received it was observed a stick down condition in the microclave, no additional damage or abnormally were observed.No matting device was returned.The microclave was dissembled and it was not observed any significant damage or residual outside the body, the spike was observed well lubricated and the seal did not additional damage or significant damage.The returned item was leak tested.There were leaks observed from the microclave that presented a stick down condition.No additional leaks were 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 # review could not be conducted because no lot number(s) was/were identified.

Event Description

The event involved a 102" (259 cm) appx 8.2 ml, pur standardbore/smallbore transfer set w/microclave® clear, dual check valve, 1.2 micron filter, luer lock, where it was reported the gummy port of microclave stuck in depressed position after 70 hours of use.There was no unexpected or prolonged care that happened.A luer lock syringe was the mating device used to access the clave.The medication was not reported by user and it is not a chemo.There was patient involvement, but no report of patient harm.Upon investigation it was observed leaks from the microclave that presented stick down condition.

• Brand Name: 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE®
• 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: 17510588
• MDR Text Key: 321330156
• Report Number: 9617594-2023-00534
• Device Sequence Number: 1
• Product Code: FMG
• 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
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC330419
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: LUER LOCK SYRINGE, UNK MFR