MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. FM; STOPCOCK, I.V. SET

Catalog Number	A1141
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved an unspecified 9.4 in appx 1.4ml, smallbore trifuse set, 3 microclave clear, nanoclave, 3 check valves that experienced leakage during use.The reporter stated that during first care, they noticed the picc line was leaking tpn and lipids from the med port into the patient's bed.The catheter near the insertion site was found clamped from the previous shift.After pausing fluids and unclamping, the clinician flushed the site and restarted the tpn and lipids.Then they noticed they were still leaking out of the med port and called to update the nnp./neonatal nurse practicioner it was also stated that patient's harm has potential for clabsi/ central line-associated bloodstream infection.The original procedure intended was unknown.The patient involved was reported to be "0.02 old and female." clarification is being requested.The device was not reprocessed and reused on a patient.There was patient involvement but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
D4 - all product information is unknown therefore the udi # is unable to be provided.Investigation summary one (1) used list# unknown, extension set with 4 claves, connected to an unknown, micro clave were returned for evaluation.It was confirmed the unknown returned item, matchs with a #a1141, some lipids residual inside the set were observed.However, no physical damage or anomalies were found.The set was tested as per procedure and no leaks or anomalies were found after the test.A dhr lot# review could not be conducted because no lot number(s) was/were identified.Complaint of leaks cannot be confirmed or replicated.

• Brand Name: FM
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21341140
• Report Number: 9617594-2025-00251
• Device Sequence Number: 11702018
• Product Code: FMG
• UDI-Device Identifier: 00887709069343
• UDI-Public: 00887709069343
• 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
• Report Date (Section B): 02/09/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 02/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 (TPN), MFR UNK.
• Patient Sex: Unknown