MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 41 CM (16") PUR CLEAR/YELLOW BIFUSE ADD-ON SET W/CLAVE®, DRY SPIKE ADAPTER; STOPCOCK, I.V. SET

Catalog Number	011-H3362
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 41 cm (16") pur clear/yellow bifuse add-on set w/clave®, dry spike adapter where it was reported one minute after introduction of the cytotoxic (busulfan) there was disintegration of the tubing downstream of the valve.Projection of cytotoxic onto the healthcare provider.The patient did not receive the entire dose (2ml missing approximately) and the device was changed, treatment was then fully administered.The medication came into contact with the patient and the healthcare provider but nothing to report regarding the effects on them.The leak was cleaned up according to the facility¿s protocol.No specific kit.No visible default on the device before use (device checked before use).A hole/cut/tear was noted 1 minute after administering the cytotoxic.There was no need for medical intervention.Nobody was harmed but the nurse was exposed to a cytotoxic.There was patient involvement.
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.
Additional Manufacturer Narrative
Received one used 011-h3362 pur clear/yellow bifuse add-on set w/clave for inspection.The yellow tubing just below the piercing pin was observed to be damaged.The reported compliant can be confirmed.The probable cause is unknown.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D4, g4: model number is not sold in the us but similar device is sold under model ch3067.This product was used for the di and 501k.D9 device returned to manufacturer on 6/5/2024.

• Brand Name: 41 CM (16") PUR CLEAR/YELLOW BIFUSE ADD-ON SET W/CLAVE®, DRY SPIKE ADAPTER
• 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: 19331230
• Report Number: 9617594-2024-00610
• Device Sequence Number: 7004114
• Product Code: FMG
• UDI-Device Identifier: 00840619024345
• UDI-Public: (01)00840619024345(17)290301(10)13922082
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K964435
• 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): 08/14/2024

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: 011-H3362
• Device Lot Number: 13922082
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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: BUSULFAN, UNK MFR
• Patient Sex: Unknown