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
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Event or Problem 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.The customer reported that the patient had 2 three way extension pieces attached to a broviac.There were cultures ordered at 1600.When they went to draw blood for the culture, the hub where they draw cultures from with one of the 3 way extensions, came off.They immediately primed a six way extension piece, scrubbed one lumen at a time and added continuous medications to six way lumen.Drugs infusing through line were fentanyl, versed, vecuronium, precedex, and 0.9 @ 5 ml/hr.Epinephrine was off but y'd in and needed to be restarted within 15 minutes after this event took place.There were no other devices being used on the patient at the time of the event that may have caused or contributed to the event.There was patient involvement; harm was no reported as a consequence of this event.
Additional Manufacturer Narrative
One photo with three (3) images were shared by the customer, in one photo shows a plastic bag with a male luer separation from the rest of the set is observed, no additional anomalies beside the mentioned are observed.Customer returned used device for evaluation.As received the nano clave y adaptor was observed to be separated from the rest of the set.The set was analyzed through uv light and insufficient solvent applied evidence was confirmed.The tube and the nano clave y pocket were measured finding within specification.Complaint of disconnection can be confirmed, the probable cause was due to insufficient solvent applied during manual process assembly in manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
One photo with three images was shared by the customer, in one photo shows a plastic bag with a male luer separation from the rest of the set is observed, no additional anomalies beside the mentioned are observed.Two used.List #a1141, were returned for evaluation.As received the nano clave y adaptor was observed to be separated from the rest of the set, both sets were analyzed through uv light and insufficient solvent applied evidence was confirmed.The tube and the nano clave y pocket were measured finding within specification.Complaint of disconnection can be confirmed, the probable cause was due to insufficient solvent applied during manual process assembly in manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH
• 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: 21039913
• Report Number: 9617594-2024-01890
• Device Sequence Number: 12670444
• Product Code: FMG
• UDI-Device Identifier: 00887709069343
• UDI-Public: (01)00887709069343(17)290101(10)13878520
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2025

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: A1141
• Device Lot Number: 13878520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 01/15/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/12/2025; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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: EPINEPHRINE, MFR UNK.; FENTANYL, MFR UNK.; PRECEDEX, MFR UNK.; VECURONIUM, MFR UNK.; VERSED, MFR UNK.
• Patient Age: 7 YR
• Patient Sex: Male