MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH-12
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.A review of the device history record is pending.Section e initial reporter full phone number: (b)(6).
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a chemoclave® bag spike with additive port dry spike.It was reported that when the device was connected to a set with physiological saline, some particles were released.The customer ruled out the possibility that the particles came from the set, as the issue occurred with sets from other brands and various lots.There was no report of any human harm.
Additional Manufacturer Narrative
The returned video from the customer showed particles in a drip chamber of an unknown item of a non-icu medical product.Without the return of the sample, it is unknown what the source of the particles is.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE
• 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: 20810793
• Report Number: 9617594-2024-01709
• Device Sequence Number: 9392682
• Product Code: ONB
• UDI-Device Identifier: 00840619023713
• UDI-Public: (01)00840619023713(17)290301(10)13921662
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 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: CH-12
• Device Lot Number: 13921662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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 PHYSIOLOGICAL SALINE, MFR UNK; UNSPECIFIED INFUSION SET, MFR UNK
• Patient Sex: Unknown