MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" (25 CM) APPX 1.0 ML, SMALLBORE EXT SET W/6-PORT NANOCLAVE¿ MANIFOLD, CHECK V; STOPCOCK, I.V. SET

Catalog Number	AM6154
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event date is unknown.(b)(6) 2024 has been used as a place holder.Investigation summary: received five (5) used.List #am6154, 10" (25 cm) appx 1.0 ml, smallbore ext set w/6-port nanoclave¿ manifold, check valve (orange, glow, blue, purple, yellow, green rings), nanoclave¿, luer lock; lot #13907590.As received, sample #3 observed to have the tubing separated from the manifold.Sample #4 observed to have the nanoclave body separated from the spike.No other physical damage or anomalies observed.Sample #2 was unable to confirm complaint.The other 2 samples, confirmed customer complaint of leaking from tubing bonding connection point.Probable cause, incomplete insertion during manufacture process in ensenada.Dhr lot #13907590 and relevant commodities were reviewed, the following discrepancy was found.Exception type: ncmr.Document id#: (b)(4).List #: x1-5020.Lot #:13854654.Report quality during functional test had (b)(4) pieces with leak.The total order quantity of (b)(4) pieces is stopped as impacted.(b)(4) sample of (b)(4) inspected pieces was rejected and in dynamic sampling (b)(4) sample of more than (b)(4) inspected pieces was rejected.
Event or Problem Description
The event involved a 10" (25 cm) appx 1.0 ml, smallbore ext set w/6-port nanoclave¿ manifold, check valve (orange, glow, blue, purple, yellow, green rings), nanoclave¿, luer lock where the customer reported a leak from the tubing bonding connection point.There was patient involvement but no harm or adverse event.The investigation found malfunction of seal separation which makes this report 3 of 4.

• Brand Name: 10" (25 CM) APPX 1.0 ML, SMALLBORE EXT SET W/6-PORT NANOCLAVE¿ MANIFOLD, CHECK V
• 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: 20537115
• Report Number: 9617594-2024-01510
• Device Sequence Number: 15127677
• Product Code: FMG
• UDI-Device Identifier: 00887709126886
• UDI-Public: (01)00887709126886(17)290201(10)13907590
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/25/2024

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: AM6154
• Device Lot Number: 13907590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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