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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch.Fluid reportedly began leaking around the spinning spiros on the secondary line as soon as the rn pushed start on the plum pump during a patient's infusion.The nurse set up for the infusion as follows: leucovorin was hung, attached secondary tubing (from the pharmacy) to the clave on the primary line.The rn closed the clamps on the secondary line and turned off the pump.The pharmacist, nick, was informed and the bag and device were returned to the pharmacy.Pharmacy changed out the secondary tubing and returned the bag; the bag did not have to be remade or wasted.
Additional Manufacturer Narrative
Although the device was requested multiple times to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.If additional information becomes available, supplemental vigilance report(s) will be filed at that time.
Event or Problem Description
A medsun medwatch uf/importer report # (b)(4) received on 05-jun-2025.
Additional Manufacturer Narrative
No 14687-15 product samples, videos or photographs were returned for investigation.The device history lot number was not reviewed; no lot number information was provided.The complaint cannot be confirmed, without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Corrected information in section d, g2, and g4.

• 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; icu medical costa rica, ltd.; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22039064
• Report Number: 9617594-2025-01029
• Device Sequence Number: 9280939
• Product Code: ONB
• UDI-Device Identifier: 00887709057012
• UDI-Public: 00887709057012
• 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: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: CL3011
• Device Lot Number: UNKNOWN
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: LEUCOVORIN, MFR UNK; UNSPECIFIED PLUM PUMP, MFR ICU MEDICAL; UNSPECIFIED SECONDARY LINE, MFR UNK
• Patient Sex: Unknown