MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.39 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATIN; STOPCOCK, I.V. SET

Catalog Number	MC33599
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 60" (152 cm) appx 0.39 ml, smallbore ext set w/microclave® clear, clamp, rotating luer that experienced breakage during patient use.The customer reported that the clear flexible piece a on the microclave at the end of the smallbore extension set stayed indented/retracted upon disconnecting after a blood transfusion.There was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
E tab initial reporter: the complaint came through: (b)(6).Upon completion of the investigation a supplemental mdr will be submitted.
Additional Manufacturer Narrative
One used device was received for evaluation.As received the following conditions were observed: the silicone plug was observed to be stuck down on the microclave.Once this was dissembled, insufficient spike lubrication on spike was observed, no additional damage or anomalies were confirmed.The complaint of a stick down can be confirmed.The probable cause of the stick down is typically due to an error during lubrication process in manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 60" (152 CM) APPX 0.39 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATIN
• 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: 20646582
• Report Number: 9617594-2024-01589
• Device Sequence Number: 7464111
• Product Code: FMG
• UDI-Device Identifier: 00887709057951
• UDI-Public: (01)00887709057951(17)280201(10)13534779
• 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): 01/01/2025

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: MC33599
• Device Lot Number: 13534779
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• 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