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	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 5" (13 cm) bag spike adapter w/spiros¿ w/red cap, vented cap where it was reported the device leaks from spiros.The event occurred during infusion of methotrexate.The chemo didn¿t come into contact with the patient or healthcare provider.It was discovered in time, so the patient/health care provider were fine.The chemo spill was cleaned up per facility protocol.The spill kit was used.The device was not reprocessed/re sterilized.There was patient involvement, but no harm reported.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.D4: only di provided as lot number is unknown.Additional reporter: (b)(6).
Additional Manufacturer Narrative
The reported complaint on the ch3034 can be confirmed.Received one (1) used ch3034 bag spike adapter w/spiros connected to a partial set.The set was leak tested per product specifications.There was leakage from the bonded connection of the male luer of the tubing to the female luer of the spiros.The spin collar of the male luer was cut and removed to observe the luer connection.A break was observed on the male luer.The luer was fully broken during testing and examined.Stress whitening and beach marks were observed on the break typical of an unintentional bending force during use.A device history report (dhr) lot# review could not be conducted because no lot number(s) was/were identified.

• 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: 20925830
• Report Number: 9617594-2024-01780
• Device Sequence Number: 12029110
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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, UNK MFR.
• Patient Sex: Unknown