MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPIKE WITH BONDED CLAVE® CONNECTOR; STOPCOCK, I.V. SET

Catalog Number	CS-53
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending.
Event or Problem Description
The complaint/event involved a spike with bonded clave® connector.Particles and white deposits were reported in the drip chamber (but were not visible in vials/bags) when the device was used with cyclophosphamide.This caused the pump to alarm during a patient's infusion at the hdj oncology/urc unit.Treatment needed to be discontinued as a new bag needed to be prepared and reconnected for treatment.The cyclophosphamide manufacturer has been notified and they will conduct tests to identify a possible incompatibility.The customer added that the pump used during infusion was a volumat pump and no issues were observed with the pump.The medication used was a to be diluted before injection vial of cyclophosphamide 1000mg/2 ml from reddy pharma.There were no holes, cuts, tear or any other defect with the spike, the patient was stable, no one was harmed during the incident, additional medical intervention was not required, there was no blood loss, there was a delay in treatment.
Additional Manufacturer Narrative
A photo was returned showing the drip chamber of the cs-53.Some particulate was observed in the drip chamber.Numerous particulates were observed in the iv bag that the bag spike was inserted into.The source of the particulate is believed to be from the infusate in the iv bag and not to be a defect in the icu medical device.The reported complaint can be confirmed.The probable cause is unknown but is unrelated to the cs-53.Lot history review could not be performed due to the unknown lot number.

• Brand Name: SPIKE WITH BONDED CLAVE® CONNECTOR
• Common Device Name: STOPCOCK, I.V. SET
• 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: 21434080
• Report Number: 9617594-2025-00330
• Device Sequence Number: 20010624
• Product Code: FMG
• UDI-Device Identifier: 00840619026011
• UDI-Public: 00840619026011
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082836
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: CS-53
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CYCLOPHOSPHAMIDE FROM REDDY PHARMA, STRENGTH 1000M.; VOLUMAT PUMP, MFR UNK.
• Patient Sex: Unknown