MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number	AM6109
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that a 10" (25 cm) smallbore ext set w/6-port nanoclave® manifold, check valve, clamp, rotating luer was found to have leaked during patient use.It was stated in the report that they utilized six port manifolds for continuous intravenous (iv) infusions on patients.Manifold running with multiple inotropes to support the patient's hemodynamics.Bedside they were reviewing lines and noted the bed to be wet where the manifold was laying.When the manifold was inspected, one of the ports was completely broken off and lying in the bed.There was no patient harm reported.
Additional Manufacturer Narrative
Received one new list# am6109, 10" smallbore ext set w/6-port nanoclave® manifold, check valve, clamp, rotating luer.No physical damage or other anomalies observed.Cannot confirm customer complaint of "one of the ports was completely broken off".A probable cause cannot be identified based on the information that has been provided.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaints.

• Brand Name: 10" SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, ROTATING
• 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: 20578654
• Report Number: 9617594-2024-01542
• Device Sequence Number: 20856860
• Product Code: FMG
• UDI-Device Identifier: 00887709077645
• UDI-Public: (01)00887709077645(17)271101(10)11757824
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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: AM6109
• Device Lot Number: 11757824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 12/02/2024
• 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: INOTROPES, UNK MFR.
• Patient Sex: Unknown