MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30 CM (12") APPX 1.3 ML, EXT SET W/2 SURPLUG® MICRO CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number IR-EK53011A

Device Problems Backflow (1064); Fluid/Blood Leak (1250)

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

Event Date 07/05/2023

Event Type  malfunction  

Event Description

The event involved a 30 cm (12") appx 1.3 ml, ext set w/2 surplug® micro clear, clamp, rotating luer.The reporter stated, ¿leakage.Trace of blood was observed wherein blood backflow was presumed to have been occurred.Upon visually checking no anomalies were observed in the valves or connectors.A three-way-cock was connected to the end of sample 1, and we attempted to flow liquid from the three-way cock side.No leakage was observed.Moreover, air tightness test was performed under 50kpa for 15secs.No leakage was observed." the event occurred during during contrast ct examination following infusion procedure.Furthermore, it was also mentioned that there was no serious injury/death, no blood loss, no adverse operator consequences, no unprotected chemo exposure and no medical/surgical intervention were required.The device was changed out/replaced with no further problems encountered.There was patient involvement, no patient harm reported no delay in critical therapy.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.Possible lot number reported lot 13496885, manufactured date 12/1/2022, expiration date 12/1/2025, e1 ¿ initial reporter postal code is (b)(6).

Manufacturer Narrative

Two (2) photos were shared by customer, where the item# ir-ek53011a and the microclave are observed, no physical damage or anomalies on the photos were observed.One (1) used sample item #ir-ek53011a was returned for evaluation.As received, internally in one of the microclave there was found an unknown dry red solution.No physical damage were observed.The sample was tested as per procedure and no internal or external leaks were observed along the device.The microclave with the internal dry red solution was dissembled and there was confirmed the presence of contamination inside the microclave body and spike.However a partial coring on seal was confirmed.Complaint of leaks can be confirmed, based on the internal dry red solution observed on microclave.However the only anomalies found was the partial coring on seal, the probable cause is typical due to an incompatible mating device during use, dfu states: the clave connector is compatible with luers with an internal diameter (id) between 1.55mm and 2.8mm.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complain.

• Brand Name: 30 CM (12") APPX 1.3 ML, EXT SET W/2 SURPLUG® MICRO CLEAR, CLAMP, ROTATING LUER
• 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: 17484632
• MDR Text Key: 321540387
• Report Number: 9617594-2023-00503
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IR-EK53011A
• Device Lot Number: PLOT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• 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: UNSPECIFIED LIQUID, UNKNOWN MFR