MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 100" (254 CM) APPX 12.8 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, ROTATING LUER,; STOPCOCK, I.V. SET

Catalog Number	B9126
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation; however, sample photos were provided.Investigation still pending.E1 initial reporter facility name: (b)(6).
Event or Problem Description
The event occurred on an unspecified date and invovled a 100" (254 cm) appx 12.8 ml, 15 drop primary set w/3 microclave®, rotating luer, filter cap where it was reported the drip chamber was filling.The customer stated that the employees clamped well when administering the medication.There was unknown patient involvement and unknown patient harm.
Additional Manufacturer Narrative
The complaint of filling drip chamber could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 100" (254 CM) APPX 12.8 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, 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: 18836476
• Report Number: 9617594-2024-00230
• Device Sequence Number: 20692755
• Product Code: FMG
• UDI-Device Identifier: 00887709013025
• UDI-Public: (01)00887709013025(17)260901(10)13702782
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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 Expiration Date: 09/01/2026
• Device Catalogue Number: B9126
• Device Lot Number: 13702782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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