MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 3.6 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK® PORT DRIP CHA; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3511
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device is not available for investigation because the customer discarded it.A review of the device history record is pending.
Event or Problem Description
The complaint/event involved a 30" (76 cm) appx 3.6 ml, 20 drop admin set w/integrated chemolock® port drip chamber, chemolock® w/red cap, bag hanger.Floaters (like small hairs or fabric pieces) in the "squeezing bulb" of the adult tubing were observed and confirmed by two staff members.This was discovered during the pharmacist's final medication check (of an unknown drug) before handing off to nursing for administration.There was no patient involvement, no adverse event/harm and there was a small delay in therapy as the dose needed to be remade.
Additional Manufacturer Narrative
The reported complaint of floaters could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed and a probable cause cannot be determined.

• Brand Name: 30" (76 CM) APPX 3.6 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: 22008731
• Report Number: 9617594-2025-00983
• Device Sequence Number: 7985785
• Product Code: ONB
• UDI-Device Identifier: 00887709057029
• UDI-Public: (01)00887709057029(17)300201(10)14317356
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: CL3511
• Device Lot Number: 14317356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2025
• 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: UNSPECIFIED MEDICATION, MFR UNK.
• Patient Sex: Unknown