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	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a 5" (13 cm) bag spike adapter w/spiros¿ w/red cap, vented cap that experienced no flow.It was stated in the report that the ch14 (reference #: (b)(4)) connected to ch3034, fluid couldn't drip.The event occurred on (b)(6) 2025 during infusion.There was concomitant drug, and concomitant device involved.An unknown chemo drug was involved in the event.Here was no delay in critical therapy and no bleedback was noted.There was a patient involvement reported, but no patient harm/adverse event reported.
Additional Manufacturer Narrative
D4 and h4 the lot#, expiration date, and manufacture date are unknown.E1 - this complaint was received through: (b)(6).The investigation is pending completion.
Additional Manufacturer Narrative
Received one used ch-14 chemoclave vented bag spike, one (used ch3034 bag spike adapter w/spiros and one used non-icu medical 150 ml burette extension set for inspection.No defects or anomalies noted.The set and all the mating devices were attempted to prime with a syringe filled with fluid.There were restrictions in flow.The ch-14 and ch3034 were disconnected.There was a stick down on the ch-14.The reported complaint could not be confirmed on the ch3034.There were no issues priming the spiros.A device history record review could not be conducted because no lot number was identified.Corrected information can be found in d10 and e3.

• 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: 21859315
• Report Number: 9617594-2025-00787
• Device Sequence Number: 20794009
• 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,Followup
• Report Date (Section B): 06/06/2025

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: CH3034
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/06/2025
• 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: CH14, CHEMOCLAVE VENTED BAG SPIKE, MFR ICU MEDICAL.; CH14, ICU MEDICAL.; UNSPECIFIED CHEMOTHERAPY, MFR UNK.
• Patient Sex: Unknown