MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 0.2 MICRON FILTER, 3 CLAMPS, ROTAT; STOPCOCK, I.V. SET

Catalog Number B33276

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

The event occurred on an unspecified date involving a 6" smallbore trifuse ext set w/3 microclave®, 0.2 micron filter, 3 clamps, rotating luer.The customer stated that on (b)(6)2024 at 12:36am risk rde reported that an infant with peripheral intravenous (iv) access with a trifuse infusing total parenteral nutrition (tpn), lipids and a medication line had a leak.The registered nurse (rn) noted that the tpn was leaking at the tpn filter on the trifuse as linen was saturated and the trifuse is sticky to touch.The event occurred during infusion.There was patient involved and unknown patient harm.

Manufacturer Narrative

The device has been discarded and is not available for evaluation.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.

• Brand Name: 6" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 0.2 MICRON FILTER, 3 CLAMPS, ROTAT
• 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: 19099636
• MDR Text Key: 340465130
• Report Number: 9617594-2024-00414
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709007192
• UDI-Public: (01)00887709007192(17)280901(10)13766552
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/12/2024

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: B33276
• Device Lot Number: 13766552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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: LIPIDS, MFR UNK; TOTAL PARENTERAL NUTRITION (TPN), MFR UNK; UNSPECIFIED MEDICATION, MFR UNK