MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 114" 10 DROP PRIMARY SET W/3 MICROCLAVE®, REMV 3-PORT NANOCLAVE® MANIFOLD W/CHEC; STOPCOCK, I.V. SET

Catalog Number	AM3011
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it is not yet received.
Event or Problem Description
The event occurred on an unspecified date and involved a 114" 10 drop primary set w/3 microclave®, remv 3-port nanoclave® manifold w/check valve, spin luer, 1 ext where the customer reported that the device broken.It was unknown if there was any patient involvement.Harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
One photo was shared by the customer, where a broken off component is shown, no additional damage or anomalies are observed.One used list # am3011 was returned for evaluation.As received, there was a crack on the female luer adaptor fill, and the thread of the male luer where the female luer is connected was visually inspected and no damage thread or anomaly was observed.The male luer iso was measured and barely passed the dimensional.The complaint of crack can be confirmed.The probable cause is due to a manufacturing molding defect issue.A dhr lot # review could not be conducted because no lot number was identified.D9 - date returned to mfg: 02may2025.Corrected information can be found in e4 - initial report sent to fda.

• Brand Name: 114" 10 DROP PRIMARY SET W/3 MICROCLAVE®, REMV 3-PORT NANOCLAVE® MANIFOLD W/CHEC
• 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: 21960927
• Report Number: 9617594-2025-00902
• Device Sequence Number: 20639882
• Product Code: FMG
• UDI-Device Identifier: 00887709086005
• UDI-Public: 00887709086005
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/19/2025

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: AM3011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 08/19/2025
• 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