MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER,; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3011
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.A review of the device history record is pending.
Event or Problem Description
Mdr report # mw5178965 was received regarding a 30" (76 cm) appx 3.3 ml, 20 drop admin set w/integrated chemolock¿ drip chamber, spiros® w/red cap, hanger.The report stated that the rn received prepared medication (actemra) for outpatient pharmacy.The medication was delivered as per usual, in a separate bag with the iv bag already spiked and primed with secondary iv set tubing.The rn removed the medication from the bag already spiked and primed with secondary iv set tubing and hung it up on the iv pole, removed the red cap to attach to the patient's primary tubing for administration and the universal spike from the secondary iv set just fell out from the attachment site of the secondary bag of actemra, resulting in the medication begin spilled.Manager follow up comments: on 8/29/2025 the rn agreed with the assessment of spike insert potentially making the insertion hole not as strong.This is the first time they have encountered this issue and wanted to raise awareness across the pharmacy just for a 2nd check on that spike being secure in the future would be useful.There was no harm to the patient.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable root cause is unable to be determined.The dhr was reviewed, and no nonconformities were found that would have led to the reported complaint.Updated information in h6.

• Brand Name: 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER,
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 23774397
• Report Number: 9617594-2025-02295
• Device Sequence Number: 18661947
• Product Code: ONB
• UDI-Device Identifier: 00887709057012
• UDI-Public: (01)00887709057012(17)300801(10)14517054
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: CL3011
• Device Lot Number: 14517054
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2025
• 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: IV BAG OF ACTEMRA, MFR UNK.; PRIMARY ADMINISTRATION TUBING, MFR UNK.
• Patient Sex: Unknown