MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 20 CM (8") APPX 0.27 ML, SMALLBORE EXT SET W/SURPLUG® MICRO CLEAR, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number IR-ET32010

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

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

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.E1 - additional contact information: (b)(6).

Event Description

The event involved a 20 cm (8") appx 0.27 ml, smallbore ext set w/surplug® micro clear, rotating luer which the customer reported a backflow of blood during patient infusion.The customer returned their device to terumo factory for evaluation connected to an intravenous (i.V.) catheter at the end.Terumo closely checked the sample, and the valve failure was confirmed.It was reported that threads of connector was confirmed to be slightly deformed.Terumo connected the sample to their in-house three way cock and attempted to flow solution from the three-way cock, as a result, leakage was observed at the top surface of the valve.The device was reported to be changed out/replaced with no further problems encountered.There was patient involvement but no patient harm.

Manufacturer Narrative

The device was received for evaluation.The complaint of back flow or leakage can be confirmed based on the residuals observed in-between the silicone seal and the body of the microclave.As received there were residuals observed in-between the silicone seal and the body of the microclave.No other anomalies observed.The microclave was disassembled.There was no damages observed on the internal spike.There was slit propagation observed on the top surface of the seal.No mating device were returned for evaluation.The probable cause of the residuals and damaged seal cannot be determined.Without the return of the used mating device a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 20 CM (8") APPX 0.27 ML, SMALLBORE EXT SET W/SURPLUG® MICRO CLEAR, 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: 17227041
• MDR Text Key: 318369845
• Report Number: 9617594-2023-00292
• Device Sequence Number: 1
• Product Code: FMG
• 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,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IR-ET32010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• 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: INTRAVENOUS CATHETER, MFR UNK.