MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 16 CM (6") SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 2 BACK CHECK VALVES, RED R; STOPCOCK, I.V. SET

Catalog Number 011-H2559

Device Problem Air/Gas in Device (4062)

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

Event Date 04/01/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned to the manufacturer for further evaluation; however, it has not yet been received.

Event Description

It was reported that, on an unknown date, a 16 cm (6") smallbore trifuse ext set w/3 microclave®, 2 back check valves, red ring, rotating luer infusion system draws in air during use with a patient.The device was reported to have been changed out/replaced with no further problems encountered.There was no report of patient harm.No additional information is available at this time.This is report 2 of 3.

Manufacturer Narrative

Leakage was confirmed at the silicone seal of the red collared microclave within the 011-h2559 smallbore trifuse ext set assembly.Subsequent investigation found that the microclave had been accessed with a sharp instrument such as a needle.The probable cause of the air infiltration or leakage is typical of access with an incompatible sharp mating device such as a needle.The directions for use (dfu) state: do not use needles or caps on microclave the device history review (dhr) was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.Additional information - d9 product received 8/5/2022.

• Brand Name: 16 CM (6") SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 2 BACK CHECK VALVES, RED R
• 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: 14213698
• MDR Text Key: 290119093
• Report Number: 9617594-2022-00101
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619019570
• UDI-Public: (01)00840619019570(17)260201(10)5198355
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H2559
• Device Lot Number: 5198355
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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