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

Model Number	AM6130
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
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 incident involved a 6" smallbore ext set w/6-port nanoclave® manifold, check valve, clamp, rotating luer on an unknown date between (b)(6) 2023 and (b)(6) 2023.There was a report of leaking from the 6-gang manifold.The problem was discovered initially attached to a patient but subsequently he believes the nurses have been flushing them to determine if they were leaking or not before attaching hem to patient.The issue presents pretty consistently as being at the distal port.The medication/drug involved was presumably normal saline.The set up was in some instances attached to a filter but not always.Furthermore, it was reported that the tubing was replaced and therapy was resumed.There were not any holes, cuts, tears or any obvious defects noted on the product.There was patient involvement reported but no patient harm.This is the third of six reports.
Additional Manufacturer Narrative
The sample was returned for evaluation.As received, no physical damage or cracks were observed along the set.The sample was prime and leak tested according to procedure.A leak between the male adaptor and manifold bond was observed in the sample, no additional leaks were observed along the set.Complaint of leaks can be confirmed based in the physical sample evaluation.The probable cause was due to an incomplete insertion during manual process assembly in ensenada.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17370443
• Report Number: 9617594-2023-00422
• Device Sequence Number: 6978544
• Product Code: FMG
• UDI-Device Identifier: 00887709087712
• UDI-Public: (01)00887709087712(17)271001(10)11379766
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 07/06/2023

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 Model Number: AM6130
• Device Catalogue Number: AM6130
• Device Lot Number: 11379766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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: NORMAL SALINE, UNK MFR.
• Patient Sex: Unknown