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	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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#: 24983 list #: x1-5020 lot #:13854654 report quality during functional test had 2 pieces with leak.The total order quantity of (b)(4) pieces is stopped as impacted.1 sample of 2 inspected pieces was rejected and in dynamic sampling 1 sample of more than 250 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 tubing separation which makes this report 2 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: 20533555
• Report Number: 9617594-2024-01505
• Device Sequence Number: 8465516
• 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