MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. NANOCLAVE® STOPCOCK; STOPCOCK, I.V. SET

Catalog Number	AC100
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
Medwatch report number (b)(4) was received regarding a nanoclave stopcock where it was reported that the needleless connector on the 3-way stopcock attached to the picc [peripherally inserted central catheter] was broken.Patient has a 2.6 dbl lumen picc.Ffp [fresh frozen plasma] transfusion was connected to the needleless connector.Shortly into the transfusion, the red lumen was alarming occluded.Troubleshooting with rnts found that the needleless connector which the ffp was connected to was broken.Unclear when/how it broke.Ffp transfusion had to be paused and disconnected temporarily.Stopcock replaced with rnts.The product is causing a pump occlusion alarm, and fluids would not run through the needleless connector of the stopcock.This results in a break in the line to replace the product.Upon inspecting the stopcock, the inner sponge of the needleless connector remains depressed.Additionally, residue was noted in the needleless connector of the stopcock, which may have contributed to the occlusion alarm.The patient involve is a 1-month-old female and no reported patient harm.
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample a comprehensive failure.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: NANOCLAVE® STOPCOCK
• 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: 24570000
• Report Number: 9617594-2026-00253
• Device Sequence Number: 8366779
• Product Code: FMG
• UDI-Device Identifier: 00887709053151
• UDI-Public: (01)00887709053151(17)300901(10)14576913
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: AC100
• Device Lot Number: 14576913
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2025
• 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: FRESH FROZEN PLASMA. MFR UNKNOWN.
• Patient Age: 1 MO
• Patient Sex: Female