MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAM; STOPCOCK, I.V. SET

Catalog Number	MC330027
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Uf/importer report # (b)(4).
Event or Problem Description
The event involved a 7" (18 cm) appx 0.52 ml, smallbore trifuse ext set w/3 microclave¿ clear, 3 clamps, luer lock.It was stated that the father came out saying that the mother had a wet shirt, and one of the lines were leaking.Nursing staff went in to examine connections and checked to see if there was a leak anywhere.It was time to change the total parenteral nutrition (tpn) and lipids, so nursing staff decided to change all tubing setup.After switching whole tubing set up, nursing staff examine the lines closer.The parents mentioned that maybe it was the hub on the trifurcator, so nursing staff started there and was able to find a small hole where liquid was leaking.There was patient involvement and unknown human harm.
Additional Manufacturer Narrative
One used sample item list #mc330027 connected into 0.9% sodium chloride 10ml syringe were returned for evaluation, as received some tpn lipids residuals was found inside the sample, evidence of kinked tubes due to the clamps activation.The set was tested according procedure and no leaks from trifurcate or any other part along the set was observed.Complaint of leaks was not able to confirmed or replicated.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to mfr on 8/30/2023.

• Brand Name: 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAM
• Common Device Name: 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: 17644955
• Report Number: 9617594-2023-00605
• Device Sequence Number: 20253926
• Product Code: FMG
• UDI-Device Identifier: 00887709076419
• UDI-Public: (01)00887709076419(17)271101(10)12878739
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: MC330027
• Device Lot Number: 12878739
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TOTAL PARENTERAL NUTRITION / LIPIDS , UNK MFR
• Patient Age: 4 MO
• Patient Sex: Female
• Patient Weight: 3 KG