MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" SMALLBORE EXT SET WITH 0.2 MICRON FILTER, CLAVE®, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	Z1931
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary twenty-eight (28) new devices were returned for evaluation.As received, no physical damage or anomalies were visually observed, no mating device was returned for evaluation.The sets were primed and no restriction was confirmed.Complaint of no flow / can't prime could not be confirmed, without the returned of the used sample.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
A complaint was received regarding a 9" (23 cm) smallbore ext set w/clave®, 0.2 micron filter, clamp, rotating luer that experienced no flow.The reporter stated that there were 29 total lot number that was having iv fluids occluded issues.The event date and the status of the product at the time of event was unknown.The event occurred during use on a patient, no adverse event and no delay in therapy.
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and (b)(6) 2025 has been used as a placeholder.The device has been received for evaluation.The investigation is pending completion.

• Brand Name: 9" SMALLBORE EXT SET WITH 0.2 MICRON FILTER, CLAVE®, CLAMP, ROTATING LUER
• 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: 22464829
• Report Number: 9617594-2025-01429
• Device Sequence Number: 19901747
• Product Code: FMG
• UDI-Device Identifier: 00887709024489
• UDI-Public: (01)00887709024489(17)291201(10)14250368
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 08/11/2025

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: Z1931
• Device Lot Number: 14250368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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