MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33122
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A lot number has been provided.A device history lot review is pending.Additional reporter: (b)(6).
Event or Problem Description
The event involved a 7" (18 cm) appx 0.51 ml, pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer where it was reported the patient came in after an hour due to blinatumomab line breaking.The spinning spiros became disconnected from the blina line even though it clicked in, and should not be able to come apart.New blina bag and line primed and restarted.There was patient involvement, but no harm reported.
Additional Manufacturer Narrative
The complaint 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 dhr was reviewed and no nonconformities were found that would have led to the reported complaint.Corrected information can be found in d10 concomitant product, e1, e3 and e4 - initial report sent to fda.Additional contacts: (b)(6).

• Brand Name: 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 23020105
• Report Number: 9617594-2025-01834
• Device Sequence Number: 10037972
• Product Code: FPA
• UDI-Device Identifier: 00887709037403
• UDI-Public: (01)00887709037403(17)290601(10)14051888
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100576
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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: MC33122
• Device Lot Number: 14051888
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BLINATUMOMAB BAG, UNK MFR.; BLINATUMOMAB, UNK MFR.; UNSPECIFIED SPINNING SPIROS, MFR ICU MEDICAL.; UNSPECIFIED TUBING, UNK MFR.; UNSPECIFIED TUBING, UNK MFR.
• Patient Sex: Unknown