MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 11 IN (28 CM) APPX 0.97 ML, SMALLBORE SET W/NANOCLAVE¿, 6-PORT, NANOCLAVE¿ MANIF; STOPCOCK, I.V. SET

Catalog Number	AM6150
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an 11 in (28 cm) appx 0.97 ml, smallbore set w/nanoclave¿, 6-port, nanoclave¿ manifold, bcv, clamp was found with the end cap disconnected from the main body.The manifold broke at the main connection port while switching the fluid line.Excessive force was not used.This defect did not occur previously.The mating device is available to be returned, and the sample does not contain any hazardous materials.A sample photo was provided.The event occurred during infusion of continuous cardiotropic medications, nutritional supportive therapy, sedation, and pain control, and intermittent antibiotic usage.Therapy for identified infusions between june 11 (date of birth) and discontinued june 16 (after the manifold was changed).There was no patient harm reported.
Additional Manufacturer Narrative
One photo was shared by the customer, where the used unknown partial extension is observed, and the body's nanoclave is observed to be separated from the manifold.No additional damage or anomalies were observed.One (1) used.List #am6150 connected to a used, unknown partial extension set.As the body's nanoclave was observed to be separated from the manifold and the spike was crushed, the body was attached to used unknown extension set.The body's nanoclave was disconnected using a pair of pliers due to a strong connection with the unknown partial extension set.The identification (id) of the returned mating device was measured and found within specification.The complaint of separation can be confirmed.The probable cause was due to unintentional forces applied during use.A device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 11 IN (28 CM) APPX 0.97 ML, SMALLBORE SET W/NANOCLAVE¿, 6-PORT, NANOCLAVE¿ MANIF
• 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: 22556415
• Report Number: 9617594-2025-01504
• Device Sequence Number: 21257715
• Product Code: FMG
• UDI-Device Identifier: 00887709122369
• UDI-Public: 00887709122369
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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: AM6150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/21/2025
• 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: EPINEPHRINE, UNK MFR; FENTANYL, UNK MFR; HYDROCORTISONE, UNK MFR; NOREPINEPHRINE, UNK MFR; PRIMIDONE, UNK MFR; SMOF LIPID, UNK MFR; UNSPECIFIED ANTIBIOTICS, UNK, MFR; VASOPRESSIN, UNK MFR
• Patient Sex: Unknown