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	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a chemoclave® bag spike with additive port dry spike where the customer reported a particle of plastic found in the drip chamber.It was noted that the particles were found during priming with d5w 250 ml bag for priming with ndc 0264-7510-20.There was no patient involvement, and no human harm.This is the third of 3 events.
Additional Manufacturer Narrative
Received the third of three used.List #ch-12, chemoclave® bag spike with additive port dry spike.With one used bd infusion device.Complaint of particulate matter can be confirmed based in the physical samples returned by customer.Reported condition was replicated when using the drip chamber spike provided by the customer and the shape of this drip chamber used to access the icu medical dry spike is considered the most relevant factor to create these particulates.Probable cause, unknown.

• 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: 20674083
• Report Number: 9617594-2024-01599
• Device Sequence Number: 12854523
• Product Code: ONB
• UDI-Device Identifier: 00840619023713
• UDI-Public: 00840619023713
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2024

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: CH-12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 11/13/2024
• 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: D5W 250 ML BAG FOR PRIMING W/ NDC 0264-7510-20
• Patient Sex: Unknown