MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10 CM (4") PUR SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 RINGS (RED, GREEN, Y; STOPCOCK, I.V. SET

Catalog Number 011-H2361

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation-it has not been received.

Event Description

The event occurred on an unknown date involving a 10 cm (4") pur smallbore trifuse ext set w/3 microclave®, 3 rings (red, green, yellow), 3 clamps, rot.Ll where the customer reported that after washing, the anti-reflux valve of the green line got stuck, causing the medicine to leak out.There was unknown patient involvement and unknown patient harm.

Manufacturer Narrative

No product samples were returned for investigation, however, a series of photographs were returned showing a the outside of a 011-h2361 unit package and another showing one of the microclaves at the proximal end of a trifuse extension set with the silicone seal stuck down.No other anomalies or damage were observed from the photo.Without return of the affected sample a comprehensive investigation cannot be conducted and a probable cause cannot be determined.The device history for lot 13542768 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.Updated information d9 no sample is available.

Manufacturer Narrative

A used sample was recovered on (b)(6) 2024 one shuntless microclave seal that was part of the 011-h2361 assembly was confirmed to be stuck down and subsequent disassembly revealed a dry internal spike that was without lubrication.This type of dry spike can result in a stick down.The probable cause of the microclave seal stick down is typical of insufficient lubrication during assembly.The device history was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• Brand Name: 10 CM (4") PUR SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 RINGS (RED, GREEN, Y
• 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: 18342335
• MDR Text Key: 330680598
• Report Number: 9617594-2023-01170
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619017712
• UDI-Public: (01)00840619017712(17)280201(10)13542768
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H2361
• Device Lot Number: 13542768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• 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: UNSPECIFIED MEDICATION, UNKNOWN MFR.