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	Chemical Exposure (2570)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.Section e additional contact: (b)(6).Products dept.Deputy supervisor: evermedical co., ltd.Productsspecialist06@evermedical.Com.(b)(6).
Event or Problem Description
The complaint/event involved a 5" (13 cm) bag spike adapter w/spiros¿ w/red cap, vented cap.Unspecified chemotherapy reportedly leaked from the spiros on the device during an infusion.There was no concomitant drug and no concomitant device.The chemo spill was cleaned up per facility protocol.There was unprotected chemo exposure.There was no bleedback involved in the event, no adverse event/patient harm and no delay in critical therapy.
Additional Manufacturer Narrative
Investigation summary received one (1) used ch3034 for inspection.No defects or anomalies noted on initial inspection.The set was leak tested per product specifications.There was leakage from the spiros.Examination of the spiros showed an extra o-ring present in the assembly.The reported complaint can be confirmed.The probable cause is due to an error during assembly in (b)(6).A dhr lot # and relevant commodities were reviewed, the following discrepancy was identified: lot #: 13797255, 13792461.Reported by mfg, component x1-4693 lot: 13792461 with an o-ring component inside the path of component on 10/20/2023.Where? area 1 eassy, cr-5, morning shift.Impacted quantity and sampling results (fail/pass): the job quantity of (b)(4) pieces is stopped.13797255, item: ch3034." 3 pieces are reported not according to the engineering drawing (extra oring), x1-4693 rev.01 lot 13792461, when? 03-11-2023.Where? during manufacturing process quantity.Impacted: (b)(4) pieces".

• 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: 20433943
• Report Number: 9617594-2024-01436
• Device Sequence Number: 8506662
• Product Code: ONB
• UDI-Device Identifier: 00840619024116
• UDI-Public: (01)00840619024116(17)281001(10)13797255
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2024

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: 13797255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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: UNSPECIFIED CHEMOTHERAPY, MFR UNK
• Patient Sex: Unknown