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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - this complaint was received through: (b)(6).The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a 5" (13 cm) bag spike adapter w/spiros¿ w/red cap, vented cap experienced separation.The reporter stated "after chemo infusing, the tube disconnected".There was patient involvement, no patient harm and no delay in critical therapy.
Additional Manufacturer Narrative
Investigation summary: received one (1) used list# mc33150, 7" (18cm) appx 0.24ml, smallbore pressure infusion (400psig) ext set w/microclave¿ clear, purple clamp, rotating luer.As received, the adapter w/spiros was observed to be disconnected from the tubing.The adapter w/spiros and tubing were observed under a uv light and found to have insufficient solvent.The reported complaint of disconnection could be confirmed.The returned sample was found to have the adapter w/spiros disconnected from the tubing.The probable cause of the disconnection is from insufficient solvent coverage during assembly in ensenada.A device history record lot# review could not be conducted because no lot number(s) was/were identified.
Additional Manufacturer Narrative
The additional information or correction of the device evaluation: received one (1) used list# ch3034, 5" (13 cm) bag spike adapter w/spiros¿ w/red cap, vented cap.As received, the adapter w/spiros was observed to be disconnected from the tubing.The adapter w/spiros and tubing were observed under a uv light and found to have insufficient solvent.The reported complaint of disconnection could be confirmed.The returned sample was found to have the adapter w/spiros disconnected from the tubing.The probable cause of the disconnection is from insufficient solvent coverage during assembly in ensenada.

• 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: 21661082
• Report Number: 9617594-2025-00525
• Device Sequence Number: 18304408
• 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,Followup
• Report Date (Section B): 06/25/2025

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: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 04/04/2025; 06/24/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 05/04/2025; 06/25/2025
• 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
• Patient Sex: Unknown