MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 25 CM (10") PUR YELLOW SMALLBORE EXT SET, 6-PORT NANOCLAVE¿ MANIFOLD W/CHECK VAL; STOPCOCK, I.V. SET

Catalog Number	011-AM6136
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The complaint/event involved a 25 cm (10") pur yellow smallbore ext set, 6-port nanoclave¿ manifold w/check valve, nanoclave¿, 4-way nanoclave¿ stopcock (red ring), rotating luer.The device reportedly leaked at the welds of one of the strands and parenteral nutrition spilled into bed during infusion.Clinical consequences noted: parenteral nutrition was stopped, the medical device was replaced and a pediaven was set up, which led to a delay in therapy.There were reported risks of infection and gas embolism.There were no holes, cuts, tears, and no visible signs of malfunction, damage, or problems with the device prior to the incident.There was no blood loss, the leak did not come into contact with the patient nor the healthcare provider.The patient was stable, the hospital stay was not extended, no one was harmed, and additional medical intervention was not required.
Additional Manufacturer Narrative
Received one used.List #011-am6136, 25 cm (10") pur yellow smallbore ext set, 6-port nanoclave¿ manifold w/check valve, nanoclave¿, 4-way nanoclave¿ stopcock (red ring), rotating luer; lot #unknown.No visual damages or anomalies were observed.The reported complaint of a leak could not be confirmed.The returned sample was tested per procedure and met product specifications and no leaks were found.A device history lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 25 CM (10") PUR YELLOW SMALLBORE EXT SET, 6-PORT NANOCLAVE¿ MANIFOLD W/CHECK VAL
• 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: 20396379
• Report Number: 9617594-2024-01394
• Device Sequence Number: 11636050
• Product Code: FMG
• UDI-Device Identifier: 00887709077645
• UDI-Public: 00887709077645
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 011-AM6136
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 12/09/2024
• 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: PARENTERAL NUTRITION, MFR UNK.; PEDIAVEN, MFR UNK.
• Patient Sex: Male
• Patient Weight: 1 KG