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	12/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E tab was completed with the information of the reporter to (b)(6) however, the initial reporter was from (b)(6) hospital, this was not entered into e1, because no further information is known.Investigation summary a photo was returned showing the tubing portion of the ch3034 indicated with a bag spike inserted.No evidence of a separation or leakage was observed.The reported complaint could not be confirmed.The lot history review could not be reviewed due to the unknown lot number.Without the return of the used sample a comprehensive failure investigation cannot be conducted.
Event or Problem Description
A complaint was received with regards to 5" (13 cm) bag spike adapter w/spiros¿ w/red cap, vented cap experienced leakage.The reporter stated "the tube disconnected from pump set and led to leak".The event occurred during infusion of nivolumab.Concomitant drug was used.Device was used for chemo.Device was not biohazard.Sample picture of a pump connected to a set, the connection between the bag spike adaptor to the to the iv spike was highlighted are available for investigation.There was patient involvement, no patient harm and there was no delay in critical therapy.The leakage from the junction between the tube and the pump set.There was no specific damage noted on the set.There was unprotected chemotherapy exposure to the patient, health care worker or other personnel.The drug did not come in contact with the patient, health care worker or other personnel.The interventions for the spillage was unknown but the chemo spill cleaned up per facility protocol with spill kit used.The lot number is unknown.The set was replaced and therapy resumed without any problem.

• 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21309212
• Report Number: 9617594-2025-00230
• Device Sequence Number: 8019862
• Product Code: ONB
• UDI-Device Identifier: 00840619024116
• UDI-Public: 00840619024116
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2025

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
• 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: 01/08/2025
• Initial Report FDA Received Date: 02/04/2025
• 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
• Patient Sex: Unknown