MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH; STOPCOCK, I.V. SET

Catalog Number A1141

Device Problem Material Puncture/Hole (1504)

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

Event Date 02/25/2024

Event Type  malfunction  

Manufacturer Narrative

A photo was returned showing the nano y-connector broken from the set.One (1) used a1141 trifuse extension set and two (2) new a1141 trifuse extension sets were received for inspection.No damages or anomalies observed on the new sets.The y-connector was broken from the set on the used set.The distal portion was not returned.The area of the break was examined.Stress whitening was observed as well as beach marks.The reported complaint can be confirmed.The probable cause of the break is due to an unintentional bending force during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Additional contact information - (b)(4).

Event Description

The event involved a 9.5" smallbore trifuse ext set w/3 microclave® clear,nanoclave® (red ring), 3 check valves, 4 clamps (yellow, light green, 2 white), luer lock where the customer reported that the iv triset tubing tore apart when clamped.There was patient involvement; harm was not reported as a consequence of this event.

• Brand Name: 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH
• 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: 18972510
• MDR Text Key: 338710494
• Report Number: 9617594-2024-00337
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709069343
• UDI-Public: (01)00887709069343(17)281201(10)13847923
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1141
• Device Lot Number: 13847923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2023
• 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
• Patient Age: 4 MO
• Patient Sex: Female