MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 3 CLAMPS,; STOPCOCK, I.V. SET

Catalog Number	011-MC3316
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - date of birth - the patients age was used to approximate the date of birth as (b)(6) 2010.E1 - this complaint was received through: ms.(b)(6), phone: (b)(6) email: (b)(6)@icumed.Com.
Event or Problem Description
A complaint was received regarding a 6" (15cm) smallbore bifuse ext set w/2 clave¿ clear, 3 clamps, spin luer, that experienced breakage during patient use.The reporter stated that during the night, the catheter broke accidentally.The set was being used on a 15-year-old female patient, with a cadd solis vip pump and blinatumomab medication was being administered.Two pictures were provided by the customer, and the product is not available for evaluation.There was delay in critical therapy, although there was no reported harm.Loliveira 10-apr-2025 update: gcm received an email on 11-apr-2025 from the icu medical sales representative confirming that the hospital could not verify the lot number of the product involved in the event.Loliveira 11-apr-2025.
Additional Manufacturer Narrative
The probable cause of a broken set could be confirmed from the photos provided.However, without the return of the sample, a comprehensive review cannot be performed and a probable cause cannot be determined.No lot was received for a device history review (dhr) review.

• Brand Name: 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 3 CLAMPS,
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21981365
• Report Number: 9617594-2025-00933
• Device Sequence Number: 4312112
• Product Code: FMG
• UDI-Device Identifier: 00840619043230
• UDI-Public: 00840619043230
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: 011-MC3316
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/07/2025
• 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 Age: 15 YR
• Patient Sex: Female