MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHA; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3528
Medical Device Problem Code	Air/Gas in Device (4062)
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 evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
Event occurred regarding a 30" (76cm) appx 6.3 ml, 20 drop admin set w/integrated chemolock¿ port drip chamber, 0.2 micron filter, chemolock¿ w/red cap, hanger where the reporter stated that "there were two instances of air bubble forming in the line between the filter and distal end of the line attached to the b port on the plum 360 dedicated set during infusion.No spills with either event.Doses were remade.There was chemo and biozard involved." there was patient involvement, no adverse event and there was delay in therapy.The medication used on the event was etoposide.
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.Lot history review was conducted and no nonconformities were found that would have led to the reported complaint.

• Brand Name: 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHA
• 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: 23000006
• Report Number: 9617594-2025-01818
• Device Sequence Number: 21212255
• Product Code: ONB
• UDI-Device Identifier: 00887709057043
• UDI-Public: (01)00887709057043(17)290201(10)13903802
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/09/2025

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: CL3528
• Device Lot Number: 13903802
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2024
• 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: ETOPOSIDE, MFR UNKNOWN.
• Patient Sex: Unknown