MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 123" (312 CM) APPX 16.0 ML, 10 DROP PRIMARY SET W/3 MICROCLAVE®, 4-WAY STOPCOCK,; STOPCOCK, I.V. SET

Catalog Number	B9900-200
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that, on an unknown date, a 123" (312 cm) appx 16.0 ml, 10 drop primary set w/3 clave¿, 4-way stopcock, spin luer was found to have been cut in half during patient use.The reporter stated that the primary tubing was cut in half.The nature of the issue is a manufacturer defect.There was a patient safety issue.No midas report was made.The department affected was surgery.The event date and the status of the product at the time of the event was unknown.There was no patient harm reported.
Additional Manufacturer Narrative
Investigation summary: the reported complaint of a cut tubing could not be confirmed.Without the return of the sample or a photo/video, a comprehensive review cannot be performed and a probable cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 123" (312 CM) APPX 16.0 ML, 10 DROP PRIMARY SET W/3 MICROCLAVE®, 4-WAY STOPCOCK,
• 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: 20588272
• Report Number: 9617594-2024-01553
• Device Sequence Number: 21033690
• Product Code: FMG
• UDI-Device Identifier: 00887709016552
• UDI-Public: (01)00887709016552(17)290601(10)14061801
• 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,Followup
• Report Date (Section B): 12/23/2024

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: B9900-200
• Device Lot Number: 14061801
• 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: 10/04/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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