MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S; STOPCOCK, I.V. SET

Catalog Number MC33332

Device Problems Precipitate in Device or Device Ingredient (1478); No Flow (2991)

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

Event Date 10/02/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If additional information becomes available a supplemental report will be submitted.Additional contact: (b)(6).

Event Description

The event involved a 128" (325 cm) appx 9.3 ml, transfer set w/microclave® clear, dual check valve, smallbore bifuse ext set w/microclave® clear (green ring), 0.2 micron filter, rotating luer.It was reported that the peripherally inserted central catheter (picc) medline ringing occlusion with post flush administration in progress, intravenous fluid (ivf) line infusing well in the alaris pump.Staff at the bedside noted precipitate in bifuse filter.Ivf line changed down to picc line clave 2 days early.Impact of the incident required ivf line change early.There was patient involvement and no adverse event reported.

• Brand Name: 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE® CLEAR, DUAL CHECK VALVE, S
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18132210
• MDR Text Key: 328062849
• Report Number: 9617594-2023-00980
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709037816
• UDI-Public: (01)00887709037816(17)280701(10)13715949
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC33332
• Device Lot Number: 13715949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• 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: ALARIS PUMP, BD; INTRAVENOUS FLUID (IVF), MFR UNK; PERIPHERALLY INSERTED CENTRAL CATHETER, MEDLINE