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	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Four list# cl3011, 30" (76 cm) appx 3.3 ml, 20 drop admin set w/integrated chemolock¿ drip chamber, spiros® w/red cap, hanger (3 used sample and 1 unused) and one (1) used, 50ml syringe; lot# unknown, one (1) used list# unknown, chemo lock, and one (1) used list, 0.9% sodium chloride injection 100ml iv bag, one (1) new, 5% dextrose injection usp 100ml iv bag.As received, the o-ring on the spiros in 2 out 4 samples was not seated correctly.No additional damage or anomalies were observed.The returned 4 samples were tested as procedure and a leaks from inside the o-ring displaced section in 2 out 4 samples was confirmed.The complaint of leaks can be confirmed.The probable cause of the dislodged o-ring is unknown.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event involved a 30" (76 cm) appx 3.3 ml, 20 drop admin set w/integrated chemolock¿ drip chamber, spiros® w/red cap, hanger where the customer reported that the hazardous drug (unspecified) leaked during patient use.The leak was either at the spiros on the secondary tubing or the microclave on the primary tubing.There was apparently 5 similar incidents from this facility, dates unspecified.All incidents involve leaking or occluded/alarming spiros.There was patient involvement, however, harm was not reported as a consequence of the events.

• 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: 21972825
• Report Number: 9617594-2025-00921
• Device Sequence Number: 20863875
• Product Code: ONB
• UDI-Device Identifier: 00887709057012
• UDI-Public: (01)00887709057012(17)290901(10)14143686
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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: 14143686
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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: MICROCLAVE, ICU MEDICAL, PRODUCT INFORMATION UNK; SPINNING SPIROS, ICU, PRODUCT INFO UNK
• Patient Sex: Unknown