MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 0.2 MICRON PEDIATRIC FILTER, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B6008
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.D4: only di provided as lot number is unknown.
Event or Problem Description
The event involved a 0.2 micron pediatric filter, rotating luer where it was reported when removing a syringe line with a 0.2 micron filter attached, the end of the filter broke off into the cap post nivolumab infusion.Unable to use cap afterwards, required a cap change in order to heparin lock the port.There was patient involvement and no adverse event.
Additional Manufacturer Narrative
Investigation summary: received one (1) used b6008 0.2 micron pediatric filter and one (1) used list #unknown bifuse extension set w/ microclaves for inspection.The male luer of the b6008 was broken inside of the microclave.Examination of the break showed one side higher than the other and stress whitening, typical of a bend break.The reported complaint of leakage can be confirmed due to the break.The probable cause of the break is due to an unintentional bending force during use.A device history record lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 0.2 MICRON PEDIATRIC FILTER, ROTATING LUER
• 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: 22045063
• Report Number: 9617594-2025-01053
• Device Sequence Number: 8781575
• Product Code: FMG
• UDI-Device Identifier: 00887709011014
• UDI-Public: 00887709011014
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: B6008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/10/2025
• 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: NIVOLUMAB INFUSION, UNK MFR
• Patient Sex: Unknown