MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20 CM) APPX 0.33 ML, SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, NANOCLAVE¿ CLAMP; STOPCOCK, I.V. SET

Catalog Number	A1061
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - this complaint was received through: (b)(6).Investigation summary: the reported complaint of a tubing break cannot be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed and a probable cause cannot be determined.No lot received for a device history review lot review.
Event or Problem Description
A complaint was received regarding a 8" (20 cm) appx 0.33 ml, smallbore ext set w/microclave¿ clear, nanoclave¿ clamp, rotating luer that experienced disconnection.It was reported that tubing snapped below med port after attaching a medication.The date of incident was on (b)(6) 2024.The medication used when the tubing snapped below the med port was ampicillin.The event did occur during patient use.

• Brand Name: 8" (20 CM) APPX 0.33 ML, SMALLBORE EXT SET W/MICROCLAVE¿ CLEAR, NANOCLAVE¿ CLAMP
• 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: 21299655
• Report Number: 9617594-2025-00221
• Device Sequence Number: 9245107
• Product Code: FMG
• UDI-Device Identifier: 00887709052949
• UDI-Public: 00887709052949
• 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
• Report Date (Section B): 02/03/2025

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: A1061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: AMPICILLIN, MFR UNK
• Patient Sex: Unknown