MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 107" (272CM) APPX 8.7 ML, TRANSF SET W/DUAL CHK VALVE, MICROCLAVE® CLR, ROT LUER; STOPCOCK, I.V. SET

Model Number MC33892

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 01/27/2022

Event Type  malfunction  

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.Additional contact names/information at the user facility were provided as follows: (b)(6).Uf/importer report# (b)(4).

Event Description

The event involved a 107" (272 cm) appx 8.7 ml, transfer set w/dual check valve, microclave® clear, rotating luer.A medsun mandatory and voluntary medwatch report form (b)(4) was received that stated that the "closed medication administration infusion set being utilized on unit for medication administration with flush to follow for infusion via central lines." the medwatch report further states that "normal saline bag attached to set, intended to allow for flush fluid to be pulled into syringe via one way valve has inadvertently infused into the patient.Volume of 90-180ml additional administered over several hours that was not intended." the customer further clarified that the reported event occurred in the hospital.Although there was patient involvement, there was no medical intervention required and no human harm.This captures the first of two events reported.

Manufacturer Narrative

No product samples, videos, or photographs were returned for investigation.The device history record (dhr) was reviewed and there were no relevant non-conformances identified that would have contributed to the reported complaint.The complaint cannot be confirmed based on the information that has been provided.

• Brand Name: 107" (272CM) APPX 8.7 ML, TRANSF SET W/DUAL CHK VALVE, MICROCLAVE® CLR, ROT 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: 14047613
• MDR Text Key: 298500140
• Report Number: 9617594-2022-00075
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709070790
• UDI-Public: (01)00887709070790(17)261101(10)5711361
• 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,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC33892
• Device Catalogue Number: MC33892
• Device Lot Number: 5711361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2022
• 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: NORMAL SALINE, MFR UNK; UNSPECIFIED SYRINGE, MFR UNK
• Patient Age: 17 MO
• Patient Sex: Male
• Patient Weight: 10 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White