MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15 CM) APPX 0.71 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 0.2 MI; STOPCOCK, I.V. SET

Catalog Number	MC33587
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There were 2 occurrences.
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
The event occurred on an unspecified date and involved a smallbore trifuse ext set w/3 microclave¿ clear, 0.2 micron filter, 3 clamps (blue, yellow, white), rotating luer.The customer reported that the filter occluded (high pressure alarms) on device for 2 days.The pharmacy checked the tpn and said that standard tpn(d12.5) was used with flow rate of 20 ml/hr.When device was changed, the high pressure alarms stop and fluid resumed without a problem.There was patient involvement, however, harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The reported complaint of an occlusion could not be confirmed.Without the return of the sample or a photo/video, an investigation could not be performed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 6" (15 CM) APPX 0.71 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 0.2 MI
• 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: 19331079
• Report Number: 9617594-2024-00609
• Device Sequence Number: 6816258
• Product Code: FMG
• UDI-Device Identifier: 00887709057906
• UDI-Public: (01)00887709057906(17)281001(10)13800537
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 06/28/2024

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: MC33587
• Device Lot Number: 13800537
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 04/16/2024; 06/14/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 05/16/2024; 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TPN, MFR UNK
• Patient Sex: Unknown