MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3034
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporter: (b)(6).The device has been received for evaluation.The investigation is pending completion.
Event or Problem Description
Event occurred regarding a 5" (13 cm) bag spike adapter w/spiros¿ w/red cap, vented cap where the reporter stated ¿a leakage was noted from an iv methotrexate (mtx) chemo at approximately 7pm in ward 8b/ patient in bed 12.The leak was first noticed by the patient¿s caregiver and subsequently escalated to the ward nurse.Iv mtx infusion had been running since 2pm with nil leakage seen until 7pm.Upon inspection, staff identified the source of the leak to be from the bag spike adaptor with spiros w/red cap.The leak was minimal (approximately 1 drop) and was contained without further issues.The team replaced the set and continued the iv mtx infusion without further incident.No additional leakage was observed after the set was changed¿.There was no serious injury/death.No blood loss.No delay in critical therapy and no adverse operator consequences.No med/surg intervention required.
Additional Manufacturer Narrative
One new list# ch3034 was returned for evaluation.As received no physical damage or anomalies were noted.The set was primed and no leak or anomalies were noted.Complaint of leaks cannot be confirmed or replicated.Without the return of the actual device, the root cause is unable to be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP
• 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: 23033691
• Report Number: 9617594-2025-01846
• Device Sequence Number: 9455418
• Product Code: ONB
• UDI-Device Identifier: 00840619024116
• UDI-Public: (01)00840619024116(17)290101(10)13890171
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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: CH3034
• Device Lot Number: 13890171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• 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: METHOTREXATE, MFR UNKNOWN.
• Patient Sex: Unknown