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

Catalog Number	AM6130
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received two (2) samples one (1) used.List #am6130, 6" smallbore ext set w/6-port nanoclave® manifold, check valve, clamp, rotating luer.One (1) used.List #am6130, 6" smallbore ext set w/6-port nanoclave® manifold, check valve, clamp, rotating luer, one (1) used.List #unknown, microclave.As received, no physical damage or other anomalies were observed leak tested both samples, sample #! had a small hole in the tubing where it mates with the manifold, tubing bond was sufficient.Probable cause, unintentional bending forces.Sample #2 noticed that the connection at the mixing valve was not secure, the male luer was not fully inserted into the female luer threads, causing the leak.Probable cause, connection not fully inserted during assembly in ensenada.Confirmed customer complaint of leaking where the tubing meets the manifold on both returned samples.D9 - date returned to mfg: 9/16/2024 a device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.
Event or Problem Description
An event on an unknown date involving a 6" smallbore ext set w/6-port nanoclave® manifold, check valve, clamp, rotating luer experienced leakage.It was reported that their cicu had leaking issues with the am6130 manifold set.They had issues where the tubing meets the manifold.Sample is available for evaluation.There was unknown patient involvement, unknown adverse event and unknown delay in therapy.An additional used device was received for testing.Please see h11 for results of the device evaluation.

• Brand Name: 6" 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: 20561098
• Report Number: 9617594-2024-01526
• Device Sequence Number: 3114160
• Product Code: FMG
• UDI-Device Identifier: 00887709087712
• UDI-Public: 00887709087712
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 10/29/2024

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: AM6130
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/29/2024
• 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
• Patient Sex: Unknown