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 Fluid/Blood Leak (1250)

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

Event Date 01/27/2024

Event Type  malfunction  

Event Description

The event involved a 9.5" (24 cm) 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 moisture was felt when repositioning lines during patient care but they were unable to determine where the moisture was coming from.A glove was placed under the connection sites of the trifuse and affter approximately 15 minutes of observation, it was noted that there was a leak at one of the lumen connection sites.The customer further stated that the open fluid pathway increases the risk for central line-associated bloodstream infection (clabsi).The patient was being treated for aortic atresia.The event occurred in unit location h4b for the hospital.There was patient involvement; harm was not reported as a consequence of this event.

Manufacturer Narrative

The device has been received for evaluation, however, investigation is not yet complete.E1 - additional contact telephone number - (b)(6).

Manufacturer Narrative

Received one (1) used a1141 smallbore trifuse extension set for inspection.No damages or anomalies noted.The set was leak tested per product specification with each of the microclaves and nanoclave in the activated and inactivated position.There was no leakage.The reported complaint was unable to be replicated or confirmed.Lot history review could not be conducted because no lot number(s) was/were identified.

• 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: 18785048
• MDR Text Key: 337191105
• Report Number: 9617594-2024-00201
• Device Sequence Number: 1
• Product Code: FMG
• 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,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 21 DA
• Patient Sex: Male