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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	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 which the customer reported leaked during patient use.The customer stated that one minute after introduction of the cytotoxic (busulfan) there was disintegration of the tubing downstream of the valve.The device was changed.There is no information available regarding the patient's state.The treatment was fully administered.There was no loss of blood.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 according to facility¿s protocol.There was no visible default noted on the device before use but a hole/cut/tear was noted 1 minute after administering the cytotoxic.There was patient involvement, however, no harm was reported.
Additional Manufacturer Narrative
The device has been returned for evaluation, however, investigation is not yet complete.
Additional Manufacturer Narrative
Received one (1) used 011-h3362 pur clear/yello 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.

• 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: 19345725
• Report Number: 9617594-2024-00624
• Device Sequence Number: 16796224
• 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): 08/13/2024

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: 011-H3362
• Device Lot Number: 13922082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• 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: 05/17/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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, MFR UNK
• Patient Sex: Unknown