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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a 0.2 micron pediatric filter, rotating luer that experienced leakage during patient use.The reporter stated that patient running atg when 0.2-micron filter between bi-fuse and straight line began leaking.Estimated 5 mls lost based on when parents noticed the leak and the wet spot on patient's clothing.The event date was on (b)(6) 2025 at 14:30 during 8b (bone marrow transplant).There was patient involvement and unknown adverse event.
Additional Manufacturer Narrative
D4 and h4 the lot#, expiration date, and manufacture date are unknown.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Additional Manufacturer Narrative
D9 - date returned to mfg: 2 may 2025.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 a spiral fracture.Crazing and a crack was found around the threads of the microclave.The reported complaint of leakage can be confirmed due to the break.The probable cause of the break is due to environmental stress cracking during use.The 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: 21922033
• Report Number: 9617594-2025-00854
• Device Sequence Number: 9030898
• 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): 07/08/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 07/08/2025
• 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
• Patient Sex: Unknown